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510(k) K822733

SIGMA REAGENT SYSTEM NO. 885 by Sigma Chemical Co. — Product Code JBE

K822733 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "SIGMA REAGENT SYSTEM NO. 885". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code JBE (Cell Enzymes (Erythrocytic And Leukocytic)), a Class II device regulated under 21 CFR 864.7100. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
September 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cell Enzymes (Erythrocytic And Leukocytic)
Device Class
Class II
Regulation Number
864.7100
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)

FDA data resources