Atlas FDA

KTQ

6 FDA 510(k) clearances · Product code

22 daysmedian time to decision
49 days90th percentile
6clearances measured

FDA profile

Official device name
Reagent, Complement
Device class
Class I (low risk)
Regulation
21 CFR 866.4100
Medical specialty
Immunology
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RecordFirmDate
SPQ(TM) ANTIBODY REAGENT SET II FOR C3 (K890417)Atlantic Antibodies1989-02-17
RABBIT COMPLEMENT (K812522)Dutchland Laboratories, Inc.1981-09-23
GUINEA PIG COMPLEMENT REGULAR (K812370)Dutchland Laboratories, Inc.1981-09-08
GUINEA PIG COMPLEMENT VIRUS ANTIBODY (K812369)Dutchland Laboratories, Inc.1981-09-08
RABBIT COMPLEMENT (K791117)Calbiochem-Behring Corp.1979-08-03
LOW-TOX-H RABBIT COMPLEMENT (K790380)Cederlane Labs , Ltd.1979-03-21

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