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510(k) K072977

DIAZYME APOLIPOPROTEIN A-1 ASSAY by General Atomics — Product Code MSJ

K072977 is an FDA 510(k) premarket notification submitted by General Atomics for the device "DIAZYME APOLIPOPROTEIN A-1 ASSAY". The FDA issued a decision of Substantially Equivalent on July 16, 2008. The device falls under product code MSJ (Apolipoproteins), a Class I device regulated under 21 CFR 862.1475. General Atomics has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2008
Date Received
October 22, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apolipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by General Atomics

  • K082488 — DIAZYME LP(A) ASSAY (January 13, 2009)
  • K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (January 22, 2008)
  • K050178 — HBA1C ENZYMATIC ASSAY (June 28, 2005)
  • K042448 — DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT (October 29, 2004)
  • K033360 — DIAZYME LITHIUM ENZYMATIC ASSAY KIT (December 23, 2003)

Other clearances for product code MSJ

  • K073488 — DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX (March 7, 2008)
  • K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (March 28, 2007)
  • K063608 — DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR (February 23, 2007)
  • K992662 — 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (February 15, 2000)
  • K970314 — SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS (April 21, 1997)
  • K964010 — IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHE (February 10, 1997)
  • K931777 — APO A-1 CHEMILUMINESCENCE ASSAY (August 16, 1993)
  • K925702 — NICHOLS APO B CHEMILUMINESCENCE ASSAY (December 23, 1992)
  • K923087 — IL TEST APOLIPOPROTEIN A1 (October 26, 1992)
  • K923080 — IL TEST APOLIPOROTEIN B (APO B) (October 26, 1992)

FDA data resources