Atlas FDA

JTT

14 FDA 510(k) clearances · Product code

76 daysmedian time to decision
94 days90th percentile
14clearances measured

FDA profile

Official device name
Susceptibility Test Powders, Antimicrobial
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1640
Medical specialty
Microbiology
Flags
Third-party review eligible
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RecordFirmDate
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN (K983310)Accumed Intl., Inc.1998-12-17
PASCO MIC AND MIC/ID PANELS (K935805)Pasco Laboratories, Inc.1994-06-13
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST (K895362)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-01
MODIFIED IMIPENEM SUSCEPTIBILITY POWDER (K880574)Merck, Sharp & Dohme1988-05-04
CIPRO (TM) DIAGNOSTIC POWDER (K872081)Miles Pharmaceuticals1987-06-15
NORFLOXACIN SUSCEPTIBILITY POWDER (K864442)Merck, Sharp & Dohme1986-12-11
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK (K860031)Organon Teknika Corp.1986-03-06
IMIPENEM SUSCEPTIBILITY POWDER (K855071)Merck, Sharp & Dohme1986-03-06
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 (K855106)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-03-06
IMIPENEM 10 MCG SENSITIVITY DISCS (K855207)Difco Laboratories, Inc.1986-03-06
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT (K830758)Miles Laboratories, Inc.1983-05-25
MOXALACTAM (K822866)Lilly Research Laboratories1982-12-28
ANTITUBERCULOUS DRUGS (SIRE) (K822329)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-09-02
MEZLIN DIAGNOSTIC REAGENT (K820578)Miles Pharmaceuticals1982-05-12

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