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510(k) K772025

URIC ACID STD. FOR QUANT. URIC ACID by Worthington Biochemical Corp. — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 11, 1977
Date Received
October 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Worthington Biochemical Corp.

  • K780389 — HDL REAGENT SET FOR LIPOPROTEINS (April 19, 1978)
  • K780096 — LDH ISOENZYME CONTROL SERUM (March 3, 1978)
  • K772356 — LDH ISOENZYME COLUMN REAGENT SET (January 24, 1978)
  • K771143 — INORGANIC PHOSPHORUS STANDARDS (July 11, 1977)
  • K770831 — STATZYME URIC ACID REAGENT (July 11, 1977)
  • K771001 — STATZYME GLUCOSE (July 11, 1977)
  • K770470 — WORTHINGTON BUN (June 2, 1977)
  • K770277 — CHOLESTEROL STANDARDS (March 1, 1977)
  • K761262 — TRIGLYCERIDES (LIPASE) REAGENT SET (December 29, 1976)
  • K761263 — CHOLESTEROL AUTOMATED REAGENT (December 29, 1976)

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