Chrysalis Intelligence · Product Codes · JGS

JGS · Electrode, Ion Specific, Sodium

Clinical Chemistry · 7 clearances · 6 unique sponsors

Device class
Class II
Regulation 862.1665
Total clearances
7
2020-02-07 → 2026-05-01
Last 12 months
1
Unique sponsors
6
Medical specialty
Clinical Chemistry
Review panel
CH
Regulation number
862.1665
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Abbott Point of Care, Inc. 2 0 2023-10-27
Abbott Laboratories 1 0 2022-03-10
Siemens Healthcare Diagnostics, Inc. 1 0 2023-07-25
Nova Biomedical Corporation 1 0 2020-04-14
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. 1 0 2023-07-20
Radiometer Medicals Aps 1 1 2026-05-01
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
82330 CPT Medium CPT for electrolyte measurement; sodium-specific coding overlaps with multi-analyte panels
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-01 K252475 Radiometer Medicals Aps ABL90 FLEX PLUS System
2023-10-27 K230275 Abbott Point of Care, Inc. i-STAT CG8+ cartridge with the i-STAT 1 System
2023-07-25 K222438 Siemens Healthcare Diagnostics, Inc. A-LYTE® Integrated Multisensor (IMT Na K Cl)
2023-07-20 K220977 Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
2022-03-10 K213486 Abbott Laboratories GLP systems Track
2020-04-14 K200403 Nova Biomedical Corporation Stat Profile Prime Plus Analyzer System
2020-02-07 K183688 Abbott Point of Care, Inc. i-STAT CHEM8+ cartridge with the i-STAT 1 System