Chrysalis Intelligence · Sponsors · Precision Biologic, Inc.

Precision Biologic, Inc.

Darmouth, CA · 5 510(k) clearances

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Total clearances
5
2020-07-17 → 2025-08-25
Last 12 months
0
Product codes
3
Most recent
2025-08-25
Name variants in FDA filings: Precision Biologic, Inc. / Precision Biologic
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GGP Test, Qualitative And Quantitative Factor Deficiency Class II Hematology 3 2025-08-25
GJT Plasma, Coagulation Factor Deficient Class II Hematology 1 2023-09-13
GFO Activated Partial Thromboplastin Class II Hematology 1 2020-10-23
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2025-08-25 K251440 CRYOcheck Chromogenic Factor VIII GGP Class II Hematology
2023-09-13 K222831 CRYOcheck Factor VIII Deficient Plasma with VWF GJT Class II Hematology
2022-12-23 K214002 CRYOcheck Chromogenic Factor IX GGP Class II Hematology
2020-10-23 K193556 Cryocheck Hex LA GFO Class II Hematology
2020-07-17 K193204 Cryocheck Chromogenic Factor VIII GGP Class II Hematology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence