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510(k) K833858

COAGULASE PLASMA, HORSE & RABBIT EDTA by Otisville Biotech, Inc. — Product Code JTL

K833858 is an FDA 510(k) premarket notification submitted by Otisville Biotech, Inc. for the device "COAGULASE PLASMA, HORSE & RABBIT EDTA". The FDA issued a decision of Substantially Equivalent on December 8, 1983. The device falls under product code JTL (Plasma, Coagulase, Human, Horse And Rabbit), a Class I device regulated under 21 CFR 866.2160. Otisville Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1983
Date Received
November 7, 1983
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 Otisville Biotech, Inc.

  • K862390 — BIOTIS BORDET GENGOU AGAR (July 3, 1986)
  • K862389 — BIOTIS ACETAMIDE AGAR (July 3, 1986)
  • K862391 — BIOTIS DESOXYCHOLATE AGAR (July 3, 1986)
  • K862393 — BIOTIS LITMUS MILK (July 3, 1986)
  • K862400 — BIOTIS KV LAKED BLOOD AGAR (July 3, 1986)
  • K862388 — BIOTIS TCBS AGAR (July 3, 1986)
  • K862387 — BIOTIS HAEMOPHILUS IDENTIFICATION QUAD (July 3, 1986)
  • K862392 — BIOTIS MOTILITY TEST MEDIUM (July 3, 1986)
  • K862396 — BIOTIS DECARBOXYLASE MEDIA, ARGININE (July 3, 1986)
  • K862398 — BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (July 3, 1986)

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)
  • 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