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510(k) K896033

FDP COLLECTION TUBES by Medical Diagnostic Technologies, Inc. — Product Code JCO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1989
Date Received
October 16, 1989
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

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  • K960438 — TINTELIZE PAI-1 KIT (June 5, 1996)
  • K961724 — U-DOA CONTROLS (June 3, 1996)
  • K961370 — LA POSITIVE CONTROL PLASMA (May 24, 1996)
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Other clearances for product code JCO

  • K955115 — VENOM TIEM REAGENT (April 3, 1996)
  • K932787 — BATROXOBIN REAGENT (November 29, 1993)
  • 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)