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510(k) K991834

CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 by Cholestech Corp. — Product Code CKD

K991834 is an FDA 510(k) premarket notification submitted by Cholestech Corp. for the device "CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772". The FDA issued a decision of Substantially Equivalent on September 9, 1999. The device falls under product code CKD (Hydrazone Colorimetry, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Cholestech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1999
Date Received
May 28, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hydrazone Colorimetry, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

Other clearances by Cholestech Corp.

  • K040579 — CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) (June 18, 2004)
  • K032027 — CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) (September 5, 2003)
  • K972012 — CHOLESTECH BUN/CREATININE TEST SYSTEM (July 24, 1997)
  • K954778 — CHOLESTECH LDX SYSTEM (November 24, 1995)
  • K946064 — TOTAL CHOLESTEROL CASSETTE (February 22, 1995)
  • K946067 — TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL (February 22, 1995)
  • K946066 — TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL (February 22, 1995)
  • K946063 — TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL (February 22, 1995)
  • K946065 — TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL (February 22, 1995)
  • K932727 — CHOLESTECH L.D.X. SYSTEM (November 9, 1993)

Other clearances for product code CKD

  • K941192 — ORTHO ALT MICROWELL TEST SYSTEM (May 16, 1995)
  • K896237 — COBAS READY ALT REAGENT (February 16, 1990)
  • K884784 — VIRGO(R) MICROWELL ALT ASSAY (December 29, 1988)
  • K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (October 13, 1988)
  • K864082 — REFLOTRON(R) ALT (GPT) (December 4, 1986)
  • K860485 — SGPT (ALT) REAGENT SET (COLORIMETRIC) (April 3, 1986)
  • K844283 — SGPT REAGENT SET (November 27, 1984)
  • K841059 — SGPT REAGENT SET (May 1, 1984)
  • K821207 — SGPT REAGENT SET (July 14, 1982)
  • K820491 — SGPT REAGENT SET (March 11, 1982)

FDA data resources