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510(k) K770277

CHOLESTEROL STANDARDS by Worthington Biochemical Corp. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1977
Date Received
February 14, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
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)
  • K772025 — URIC ACID STD. FOR QUANT. URIC ACID (November 11, 1977)
  • 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)
  • K761262 — TRIGLYCERIDES (LIPASE) REAGENT SET (December 29, 1976)
  • K761263 — CHOLESTEROL AUTOMATED REAGENT (December 29, 1976)

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