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510(k) K811864

SIGMA PROCEDURE 265-UV by Sigma Chemical Co. — Product Code CED

K811864 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "SIGMA PROCEDURE 265-UV". The FDA issued a decision of Substantially Equivalent on July 31, 1981. The device falls under product code CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase), a Class I device regulated under 21 CFR 862.1520. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1981
Date Received
July 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
Device Class
Class I
Regulation Number
862.1520
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)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933691 — SIGMA CO2 ALKALINE BUFFER 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 CED

  • K894288 — PHOSPHORUS TEST ITEM NUMBER 65416 (August 31, 1989)
  • K840151 — EKTACHEM CLINICAL CHEM. SLIDES (March 22, 1984)
  • K833710 — BTC URINE LH ASSAY (January 30, 1984)
  • K820832 — PHOSPHORUS IL (April 15, 1982)
  • K812670 — SANDARE FAST 340 PHOSPHORUS PROCEDURE (October 2, 1981)
  • K811222 — INORGANIC PHOSPHORUS REAGENTS (May 21, 1981)
  • K802420 — CENTRIFICHEM INORGANIC PHOSPHORUS (October 31, 1980)
  • K790662 — CENTRIFICHEM INORGANIC PHOSPHORUS (May 15, 1979)

FDA data resources