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510(k) K840210

REPTILASE-R HA35 by Wellcome Diagnostics — Product Code JCO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1984
Date Received
January 19, 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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  • K854852 — WELLCOGEN BACTERIAL ANTIGEN KIT (February 4, 1986)
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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)
  • K843207 — REPTILASE -PC (October 23, 1984)
  • K780355 — ATROXIN (April 18, 1978)