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510(k) K811982

STAPHASE* by Analytical Products, Inc. — Product Code JTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1981
Date Received
July 13, 1981
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

Other clearances by Analytical Products, Inc.

  • K924814 — API 20E/UNISCEPT 20E (March 11, 1993)
  • K923684 — API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC (December 3, 1992)
  • K922926 — API UNISCEPT KB/TYPE 2 AND 3 (October 13, 1992)
  • K901559 — MODIFICATION TO API UNISCEPT 20GP (September 10, 1990)
  • K901390 — DMAC INDOLE REAGENT (April 16, 1990)
  • K895796 — API UNISCEPT KB (November 13, 1989)
  • K884510 — MODIFICATION MICRO-MIC (November 22, 1988)
  • K884509 — MODIFICATION MIC/API UNISCEPT(R) (November 22, 1988)
  • K880598 — MODIFICATIONS TO API UNISCEPT (R) KB (March 23, 1988)
  • K874466 — API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC (December 9, 1987)

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)
  • K840553 — HEMASTAPH (April 13, 1984)
  • 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)