Atlas FDA

JSW

6 FDA 510(k) clearances · Product code

39 daysmedian time to decision
128 days90th percentile
6clearances measured

FDA profile

Official device name
Kit, Identification, Glucose Nonfermenter
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Medical specialty
Microbiology
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RecordFirmDate
RAPID NFT, MODIFICATION (K922768)Biomerieux Vitek, Inc.1992-10-14
RAPID NF SYSTEM (K900517)Innovative Diagnostic Systems, Inc.1990-03-13
AUSTIN NONFERMENTER KIT (K870769)Austin Biological Laboratories1987-04-03
PSEUDO-PALETTE TM (K790992)Micro-Palettes, Inc.1979-06-22
NON-FERMENTER SYSTEM (K772112)Corning Medical & Scientific1977-11-17
PANEL, GNF, MICRO-ID (K770745)Micro-Media Systems, Inc.1977-06-23

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