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510(k) K780355

ATROXIN by Sigma Chemical Co. — Product Code JCO

K780355 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "ATROXIN". The FDA issued a decision of Substantially Equivalent on April 18, 1978. The device falls under product code JCO (Bothrops Atrox Reagent), a Class II device regulated under 21 CFR 864.8100. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1978
Date Received
March 3, 1978
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 Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

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)
  • K843207 — REPTILASE -PC (October 23, 1984)
  • K840210 — REPTILASE-R HA35 (April 23, 1984)

FDA data resources