Atlas FDA

DNO

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Hemagglutination Inhibition, Gentamicin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3450
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS (K964009)Beckman Instruments, Inc.1997-02-11

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Every clearance here is in the API, with alerts when new ones post.