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510(k) K843207

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

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

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Other clearances for product code JCO

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