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510(k) K881237

CREATINE KINASE (CK) REAGENT SET by Tech-Neal Scientific, Inc. — Product Code JHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1988
Date Received
March 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
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)
  • K880237 — CHOLESTEROL (April 28, 1988)
  • K881240 — CHLORIDE REAGENT SET (April 28, 1988)
  • K880277 — URIC ACID REAGENT SET (April 18, 1988)
  • K880844 — ALBUMIN REAGENT SET (April 5, 1988)
  • K880843 — CREATININE REAGENT SET (KINETIC) (April 5, 1988)
  • K880845 — CALCIUM REAGENT SET (April 5, 1988)

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