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510(k) K790211

DEHYDROGENOSE, GLUCOSE PHOSPHATE by Sigma Chemical Co. — Product Code JBL

K790211 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "DEHYDROGENOSE, GLUCOSE PHOSPHATE". The FDA issued a decision of Substantially Equivalent on March 15, 1979. The device falls under product code JBL (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative), a Class II device regulated under 21 CFR 864.7360. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1979
Date Received
January 31, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
Device Class
Class II
Regulation Number
864.7360
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 JBL

  • K990957 — ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K (May 11, 1999)

FDA data resources