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510(k) K780096

LDH ISOENZYME CONTROL SERUM by Worthington Biochemical Corp. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1978
Date Received
January 18, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Worthington Biochemical Corp.

  • K780389 — HDL REAGENT SET FOR LIPOPROTEINS (April 19, 1978)
  • K772356 — LDH ISOENZYME COLUMN REAGENT SET (January 24, 1978)
  • K772025 — URIC ACID STD. FOR QUANT. URIC ACID (November 11, 1977)
  • K771001 — STATZYME GLUCOSE (July 11, 1977)
  • K771143 — INORGANIC PHOSPHORUS STANDARDS (July 11, 1977)
  • K770831 — STATZYME URIC ACID REAGENT (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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