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510(k) K963508

DISPENS-O-DISC MEROPENEM by Difco Laboratories, Inc. — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1996
Date Received
September 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type

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  • K941016 — DISPENS-O-DISC(TM) NITROCEFIN (June 30, 1994)
  • K934894 — CULTURESWAB TRANSPORT SYSTEM (February 22, 1994)

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