FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K Number: K982669 · Decision Sep 9, 1998
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
322
Applicant Total
36
Review Days
40

Basic Information

Device Name
OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K Number
K982669
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
866.1620
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
OXOID, LTD.
Date Received
July 31, 1998
Decision Date
September 9, 1998
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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Other Clearances by OXOID, LTD.

K Number Device Name
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K042157 DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K011710 OXOID PBP2 1 LATEX AGGLUTINATION TEST
K012588 OXOID PYLORI TEST KIT, MODEL DR0130M
K010537 LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010536 MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K000930 GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K000928 QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K993401 DRYSPOT E.COLI 0157 KIT
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