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510(k) K880629

CREATININE by Tech-Co, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1988
Date Received
February 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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  • K920766 — T4 EIA BEAD ASSAY (April 17, 1992)
  • K920716 — DIRECT PREGNANCY TEST (March 24, 1992)
  • K902574 — POTASSIUM REAGENT SET (July 10, 1990)
  • K901561 — IRON/TOTAL IRON BINDING CAPACITY (May 17, 1990)
  • K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (October 13, 1988)
  • K883386 — CHLORIDE (October 6, 1988)
  • K883683 — HEMOGLOBIN (October 6, 1988)
  • K881172 — BILIRUBIN (DIRECT) (June 7, 1988)

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