Atlas FDA

GOY

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Antisera, Agglutinating, B. Pertussis, All
Device class
Class I (low risk)
Regulation
21 CFR 866.3065
Medical specialty
Microbiology
Adverse events (MAUDE)
1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CHANGE IN STERILIZATION PROCEDURE (K781727)Absorbent Cotton Co., Inc.1978-12-04

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