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510(k) K852519

DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE by E.I. Dupont DE Nemours & Co., Inc. — Product Code JCO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1985
Date Received
June 17, 1985
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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  • K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (March 21, 1995)

Other clearances for product code JCO

  • K955115 — VENOM TIEM REAGENT (April 3, 1996)
  • K932787 — BATROXOBIN REAGENT (November 29, 1993)
  • K896033 — FDP COLLECTION TUBES (October 27, 1989)
  • K843207 — REPTILASE -PC (October 23, 1984)
  • K840210 — REPTILASE-R HA35 (April 23, 1984)
  • K780355 — ATROXIN (April 18, 1978)