Atlas FDA

LOP

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Solution, Antimicrobial
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1640
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2009: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TROBICIN SUSCEPTIBILITY POWDER (K902004)The Upjohn Co.1990-05-15
ZEFAZONE SUSCEPTIBILITY POWDER (K900455)The Upjohn Co.1990-02-09
STOCK ANTIMICROBIC SOLUTIONS (K810471)Cathra International, Inc.1981-04-01

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