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

DRYSLIDE CEFIN

K Number: K930702 · Decision Dec 22, 1993
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
327
Applicant Total
121
Review Days
315

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Basic Information

Device Name
DRYSLIDE CEFIN
K Number
K930702
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
866.1620
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Difco Laboratories, Inc.
Date Received
February 10, 1993
Decision Date
December 22, 1993
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 Difco Laboratories, Inc.

K Number Device Name
K971211 DISPENS-O-DISC SPARFLOXACIN
K971120 DISPENS-O-DISC (TM) LEVOFLOXACIN
K963508 DISPENS-O-DISC MEROPENEM
K961148 CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)
K954783 DRYSLIDE CARTARRHALIS
K954784 DRYSIDE NEISSERIA
K953129 ESP CULTURE SYSTEM - MYCO
K950706 DRYSLIDE COAGULASE
K944275 DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.
K941016 DISPENS-O-DISC(TM) NITROCEFIN
Search all 121 clearances from Difco Laboratories, Inc. →