Resp. Panel 1 Indirect Immunofluorescence Assay

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K922801 ↗

FDA Product Code

GNY

Device Class

Class I

Regulation

21 CFR Part 866.3020

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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