Home / 510(k) Clearances / K760477

510(k) K760477

REAGENTS-4 FOR URIC ACID DETERMINATION by Simmler & Son, Inc. — Product Code CDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1976
Date Received
August 17, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Phosphotungstate Reduction
Device Class
Class I
Regulation Number
862.1775
Review Panel
CH
Submission Type

Other clearances by Simmler & Son, Inc.

  • K780817 — GLOBIN-TERGE (July 27, 1978)
  • K771904 — GLYCEROL KINASE (December 6, 1977)
  • K771906 — PHOSPHATE (December 6, 1977)
  • K771905 — GLYCEROL SUBSTRATE (December 6, 1977)
  • K771903 — LIPASE (December 6, 1977)
  • K761086 — REAGENTS (January 12, 1977)
  • K760476 — REAGENT, LACTATE DEHYDROGENASE (November 1, 1976)
  • K760475 — REAGENT, CALCIUM DETERMINATION (October 29, 1976)
  • K760480 — REAGENT, TOTAL PROTEIN DETERMINATION (October 29, 1976)
  • K760474 — REAGENT, ALKALINE PHOSPHATASE DETERM. (October 29, 1976)

Other clearances for product code CDH

  • K850933 — URIC ACID (June 25, 1985)
  • K841067 — URIC ACID REAGENT SET (May 1, 1984)
  • K821213 — URIC ACID REAGENT SET (July 13, 1982)
  • K813076 — PHOSPHOTUNGSTATE REDUCTION, URIC ACID (November 16, 1981)
  • K810088 — URIC ACID (TPTZ) COLORINMETRIC (January 28, 1981)
  • K800672 — SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC (May 28, 1980)
  • K800190 — STANBIO DIRECT URIC ACID TEST SET #0770 (February 13, 1980)
  • K792412 — ELVI URIC ACID (December 7, 1979)
  • K792403 — ELVI URIC ACID-COLORIMETRIC METHOD (December 7, 1979)
  • K790019 — SERUM, URIC ACID DETERMINATION (February 26, 1979)