FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D

K Number: K812916 · Decision Nov 6, 1981
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
322
Applicant Total
39
Review Days
18

Basic Information

Device Name
MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D
K Number
K812916
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
866.1620
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Applicant
GENERAL DIAGNOSTICS
Date Received
October 19, 1981
Decision Date
November 6, 1981
Product Code
JTN
Advisory Committee
Microbiology
Review Advisory Committee
MI
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JTN Susceptibility Test Discs, Antimicrobial

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K Number Device Name
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K864993 QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
K863877 BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
K842307 GENERAL DIAG. CEFONICID 30MCG ANTIMIC
K841465 GENERAL DIAGNOSTICS PLATELET ANTIBODY
K833709 CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK
K832653 CEFUROXIME 30MCG. SUSCEP DISK
K831179 CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP
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