Chrysalis Intelligence · Sponsors · Ihealth Labs, Inc.

Ihealth Labs, Inc.

Sunnyvale, CA, US · 4 510(k) clearances

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Total clearances

4

2024-05-31 → 2025-12-12

Last 12 months

2

Product codes

3

Most recent

2025-12-12

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Class II	Microbiology	2	2025-12-12
MWI	—	—	—	1	2025-02-03
QYT	Over-The-Counter Covid-19 Antigen Test	Class II	Microbiology	1	2024-05-31

Filings

All 510(k) clearances (4)

Date	K-number	Device	Code	Class	Specialty
2025-12-12	K251092	iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro	SCA	Class II	Microbiology
2025-12-12	K251085	iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro	SCA	Class II	Microbiology
2025-02-03	K243146	iCare APP	MWI	—	—
2024-05-31	K233842	iHealth COVID-19 Antigen Rapid Test	QYT	Class II	Microbiology