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510(k) K955115

VENOM TIEM REAGENT by Medical Diagnostic Technologies, Inc. — Product Code JCO

K955115 is an FDA 510(k) premarket notification submitted by Medical Diagnostic Technologies, Inc. for the device "VENOM TIEM REAGENT". The FDA issued a decision of Substantially Equivalent on April 3, 1996. The device falls under product code JCO (Bothrops Atrox Reagent), a Class II device regulated under 21 CFR 864.8100. Medical Diagnostic Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1996
Date Received
November 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bothrops Atrox Reagent
Device Class
Class II
Regulation Number
864.8100
Review Panel
HE
Submission Type

Other clearances by Medical Diagnostic Technologies, Inc.

  • K062229 — CTC WORKSTATION, MODEL 2200 (September 11, 2006)
  • K972209 — SPECTROLYSE HEPARIN (ANTI-IIA) (August 12, 1997)
  • K963106 — CHROMOLIZE PAI-1 KIT (November 18, 1996)
  • K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA) (August 14, 1996)
  • K962489 — CHROMOLIZE TPA ASSAY KIT (July 31, 1996)
  • K960438 — TINTELIZE PAI-1 KIT (June 5, 1996)
  • K961724 — U-DOA CONTROLS (June 3, 1996)
  • K961370 — LA POSITIVE CONTROL PLASMA (May 24, 1996)
  • K955738 — BIOCLOT PROTEIN S (February 29, 1996)
  • K952746 — ALKALINE PHOSPHATASE REAGENT SYSTEM (November 27, 1995)

Other clearances for product code JCO

  • K932787 — BATROXOBIN REAGENT (November 29, 1993)
  • K896033 — FDP COLLECTION TUBES (October 27, 1989)
  • K852519 — DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE (August 12, 1985)
  • K843207 — REPTILASE -PC (October 23, 1984)
  • K840210 — REPTILASE-R HA35 (April 23, 1984)
  • K780355 — ATROXIN (April 18, 1978)

FDA data resources