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510(k) K950706

DRYSLIDE COAGULASE by Difco Laboratories, Inc. — Product Code JTL

K950706 is an FDA 510(k) premarket notification submitted by Difco Laboratories, Inc. for the device "DRYSLIDE COAGULASE". The FDA issued a decision of Substantially Equivalent on May 16, 1995. The device falls under product code JTL (Plasma, Coagulase, Human, Horse And Rabbit), a Class I device regulated under 21 CFR 866.2160. Difco Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1995
Date Received
February 15, 1995
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 Difco Laboratories, Inc.

  • K971211 — DISPENS-O-DISC SPARFLOXACIN (April 14, 1997)
  • K971120 — DISPENS-O-DISC (TM) LEVOFLOXACIN (April 14, 1997)
  • K963508 — DISPENS-O-DISC MEROPENEM (September 26, 1996)
  • K961148 — CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) (April 26, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)
  • K954784 — DRYSIDE NEISSERIA (January 30, 1996)
  • K953129 — ESP CULTURE SYSTEM - MYCO (December 26, 1995)
  • K944275 — DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. (December 19, 1994)
  • K941016 — DISPENS-O-DISC(TM) NITROCEFIN (June 30, 1994)
  • K934894 — CULTURESWAB TRANSPORT SYSTEM (February 22, 1994)

Other clearances for product code JTL

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

FDA data resources