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510(k) K951332

PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT by Dade Intl., Inc. — Product Code CKA

K951332 is an FDA 510(k) premarket notification submitted by Dade Intl., Inc. for the device "PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT". The FDA issued a decision of Substantially Equivalent on June 19, 1995. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Dade Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1995
Date Received
March 9, 1995
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 Dade Intl., Inc.

  • K974343 — DADE INNOVIN (July 22, 1998)
  • K970505 — DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/ (November 17, 1997)
  • K973974 — DADE TRU-LIQUID CARDIAC CONTROL (November 6, 1997)
  • K973668 — CARDIAC TROPONIN-I (TROP) CALIBRATOR (October 20, 1997)
  • K972524 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (September 8, 1997)
  • K972782 — DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (August 15, 1997)
  • K972287 — DADE TRU-LIQUID BILIRUBIN CONTROL (July 7, 1997)
  • K964660 — PARAMAX CHOLESTEROL REAGENT (June 4, 1997)
  • K970676 — DRIED GRAM-NEGATIVE MIC/COMBO PANELS (May 2, 1997)
  • K964715 — PARAMAX SALICYLATE REAGENT (April 25, 1997)

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