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510(k) K812602

RABBIT COAGULASE PLASMA by Dutchland Laboratories, Inc. — Product Code JTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1981
Date Received
September 15, 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 Dutchland Laboratories, Inc.

  • K821911 — S-MEM-JOKLIK'S POWDER (July 27, 1982)
  • K821918 — POWDERED RPMI-1603 MEDIUM (July 27, 1982)
  • K821912 — MCCOY'S POWDER MEDIUM 5A SUSPENSION (July 27, 1982)
  • K821919 — POWDERED RPMI-1634 MEDIUM (July 27, 1982)
  • K821914 — COON'S F-12 POWDER MEDIUM (July 27, 1982)
  • K821916 — IMPROVED MEM-RICHTER'S POWDER MODIF. (July 27, 1982)
  • K821913 — ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM (July 27, 1982)
  • K821917 — WAYMOUTH'S POWDER MEDIUM (July 27, 1982)
  • K821915 — BME AUTOCLAVABLE MEDIUM (July 27, 1982)
  • K820930 — FISCHER'S POWDERED MEDIUM (April 21, 1982)

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)
  • K811982 — STAPHASE* (July 28, 1981)