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510(k) K880238

TRIGLYCERIDE by Tech-Neal Scientific, Inc. — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1988
Date Received
January 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

Other clearances by Tech-Neal Scientific, Inc.

  • K882256 — MAGNESIUM REAGENT SET (August 8, 1988)
  • K882459 — DIAZO, COLORIMETRIC BILIRUBIN (August 2, 1988)
  • K881239 — GAMMA GLUTAMYL TRANSFERASE REAGENT SET (May 31, 1988)
  • K881241 — TOTAL BILIRUBIN REAGENT (May 27, 1988)
  • K881237 — CREATINE KINASE (CK) REAGENT SET (April 28, 1988)
  • K880237 — CHOLESTEROL (April 28, 1988)
  • K881240 — CHLORIDE REAGENT SET (April 28, 1988)
  • K880277 — URIC ACID REAGENT SET (April 18, 1988)
  • K880843 — CREATININE REAGENT SET (KINETIC) (April 5, 1988)
  • K880844 — ALBUMIN REAGENT SET (April 5, 1988)

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