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510(k) K771033

SMAC SYS., SUPPLEMENTAL PRODUCTS FOR by Mid Tech, Inc. — Product Code CKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1977
Date Received
June 9, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

Other clearances by Mid Tech, Inc.

  • K810951 — REAGENTS FOR QUANT. ENZYMATIC DETER.-TR. (April 23, 1981)
  • K791869 — GLUCOSE OXIDASE (FRINDER) KIT (October 1, 1979)
  • K791313 — ARS, CHEMISTRY (August 16, 1979)
  • K770508 — SMAC SYSTEM (May 9, 1977)

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  • K974003 — ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 (December 5, 1997)
  • K971323 — ALT OR SGPT (April 21, 1997)
  • K965134 — ALT/SGPT (February 18, 1997)
  • K961123 — ALT INCORPORATING DST (April 25, 1996)