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510(k) K843207

REPTILASE -PC by Bio/Data Corp. — Product Code JCO

K843207 is an FDA 510(k) premarket notification submitted by Bio/Data Corp. for the device "REPTILASE -PC". The FDA issued a decision of Substantially Equivalent on October 23, 1984. The device falls under product code JCO (Bothrops Atrox Reagent), a Class II device regulated under 21 CFR 864.8100. Bio/Data Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1984
Date Received
August 15, 1984
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 Bio/Data Corp.

  • K001891 — MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C (July 12, 2000)
  • K943153 — MICROSAMPLE COAGULATION ANALYZER (March 24, 1995)
  • K893650 — PLATELET AGGREGATION PROFILER MODEL PAP-4C (June 23, 1989)
  • K881150 — KINETIC FIBRINOGEN ASSAY (March 28, 1988)
  • K873382 — PLATELET EXTRACT REAGENT (November 20, 1987)
  • K860751 — VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA (March 18, 1986)
  • K860342 — MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP (March 4, 1986)
  • K854546 — MICROSAMPLE COAGULATION ANALYSER MODEL 110P (January 7, 1986)
  • K853897 — CITREX H (October 10, 1985)
  • K853246 — CALCIUM CHLORIDE (August 13, 1985)

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)
  • K852519 — DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE (August 12, 1985)
  • K840210 — REPTILASE-R HA35 (April 23, 1984)
  • K780355 — ATROXIN (April 18, 1978)

FDA data resources