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510(k) K852889

GENERAL DIAGNOSTICS RAPID E. COLI TEST by Warner-Lambert Co. — Product Code JTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1985
Date Received
July 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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  • K850412 — GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY (May 8, 1985)
  • K850409 — GEN. DIAG. CHROMOSTRATE REF. PLASMA (May 8, 1985)

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  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)