Atlas FDA

MOXALACTAM

FDA 510(k) clearance K822866 · decided 1982-12-28

Clearance details

K-number
K822866
Device name
MOXALACTAM
Applicant
Lilly Research Laboratories
Decision
Substantially Equivalent
Date received
1982-09-27
Decision date
1982-12-28
Days to decision
92 days
Clearance type
Traditional
Product code
JTT
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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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
ANTITUBERCULOUS DRUGS (SIRE) (K822329)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-09-02

Recalls involving this device

No recalls on record reference this clearance.