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510(k) K851228

GENERAL DIAGNOSTICS AUGMENTIN 30MCG SUSCEP DISK by Warner-Lambert Co. — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1985
Date Received
March 26, 1985
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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  • K852967 — GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK (August 19, 1985)
  • K852689 — GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK (August 19, 1985)
  • K852843 — GENERAL DIAGNOSTICS COAG-A-MATE XC (August 13, 1985)
  • K852889 — GENERAL DIAGNOSTICS RAPID E. COLI TEST (July 23, 1985)
  • K850409 — GEN. DIAG. CHROMOSTRATE REF. PLASMA (May 8, 1985)
  • K850412 — GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY (May 8, 1985)

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