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510(k) K840553

HEMASTAPH by Remel Co. — Product Code JTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1984
Date Received
February 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulase, Human, Horse And Rabbit
Device Class
Class I
Regulation Number
866.2160
Review Panel
MI
Submission Type

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  • K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (November 14, 2003)
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  • K031565 — XPECT INFLUENZA A/B (July 17, 2003)

Other clearances for product code JTL

  • K950706 — DRYSLIDE COAGULASE (May 16, 1995)
  • K883333 — RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT (August 25, 1988)
  • K870945 — RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 (June 10, 1987)
  • K861312 — LYFO-KWIK (TM) COAGULASE PLASMA (April 18, 1986)
  • K833988 — API STAPHASE III (December 22, 1983)
  • K833858 — COAGULASE PLASMA, HORSE & RABBIT EDTA (December 8, 1983)
  • K822988 — COAGULASE PLASMA-CITRATED & EDTA (November 5, 1982)
  • K820177 — COAGULASE PLASMA (February 5, 1982)
  • K812602 — RABBIT COAGULASE PLASMA (September 29, 1981)
  • K811982 — STAPHASE* (July 28, 1981)