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510(k) K770902

COLORIMETRIC DETERM. SOCITRATE DEHYDRO. by Sigma Chemical Co. — Product Code JKH

K770902 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "COLORIMETRIC DETERM. SOCITRATE DEHYDRO.". The FDA issued a decision of Substantially Equivalent on July 14, 1977. The device falls under product code JKH (Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen), a Class I device regulated under 21 CFR 862.1420. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1977
Date Received
May 16, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen
Device Class
Class I
Regulation Number
862.1420
Review Panel
CH
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