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510(k) K810088

URIC ACID (TPTZ) COLORINMETRIC by Bio-Analytics Laboratories, Inc. — Product Code CDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1981
Date Received
January 13, 1981
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 Bio-Analytics Laboratories, Inc.

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  • K860213 — ALBUMIN REAGENT KIT (February 11, 1986)
  • K851513 — ULTRA-VIOLET BUN REAGENT KIT (May 20, 1985)
  • K851514 — ULTRA-VIOLET GLUCOSE REAGENT (May 20, 1985)
  • K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 5, 1985)
  • K832771 — ERYTHROCYTE TEST (October 28, 1983)
  • K832567 — ACETAMINOPHEN(PARACETAMOL (September 12, 1983)
  • K831414 — COLORIMETRIC BUN (June 16, 1983)
  • K821934 — BIO-CAL OPERATION CHECK KIT (July 20, 1982)

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)
  • 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)
  • K772082 — ENZAC URIC ACID 100-TEST KIT (November 28, 1977)