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510(k) K771033

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

K771033 is an FDA 510(k) premarket notification submitted by Mid Tech, Inc. for the device "SMAC SYS., SUPPLEMENTAL PRODUCTS FOR". The FDA issued a decision of Substantially Equivalent on August 4, 1977. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Mid Tech, Inc. has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code CKA

  • K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZE (June 7, 2013)
  • K113382 — ACE ALT REAGENT (July 19, 2012)
  • K061020 — DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARB (May 10, 2006)
  • K020487 — CARESIDE ALT (June 4, 2002)
  • K980028 — ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (February 2, 1998)
  • K973869 — TRACE REAGENT LINE FOR THE COBAS MIRA (January 7, 1998)
  • 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)

FDA data resources