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510(k) K772025

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

K772025 is an FDA 510(k) premarket notification submitted by Worthington Biochemical Corp. for the device "URIC ACID STD. FOR QUANT. URIC ACID". The FDA issued a decision of Substantially Equivalent on November 11, 1977. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Worthington Biochemical Corp. has at least 10 other 510(k) clearances on record.

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)

Other clearances for product code JIS

  • K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (August 14, 2012)
  • K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (May 31, 2006)
  • K060266 — DIMENSION IRON CALIBRATOR (March 9, 2006)
  • K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (December 23, 2005)
  • K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (November 7, 2003)
  • K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (October 21, 2003)
  • K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (August 13, 2003)
  • K030964 — CALIBRATION PLASMA LMW HEPARIN (June 6, 2003)
  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)
  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)

FDA data resources