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510(k) K851389

APO B RIA KIT by Iso-Tex Diagnostics — Product Code MSJ

K851389 is an FDA 510(k) premarket notification submitted by Iso-Tex Diagnostics for the device "APO B RIA KIT". The FDA issued a decision of Substantially Equivalent on July 10, 1985. The device falls under product code MSJ (Apolipoproteins), a Class I device regulated under 21 CFR 862.1475. Iso-Tex Diagnostics has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1985
Date Received
April 9, 1985
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 Iso-Tex Diagnostics

  • K840105 — APO A-I RIA KIT-HUMAN PLASMA APOLIP- (January 10, 1984)
  • K782081 — RIA SYSTEM, PARATHYROID HORMONE (March 21, 1979)

Other clearances for product code MSJ

  • K072977 — DIAZYME APOLIPOPROTEIN A-1 ASSAY (July 16, 2008)
  • 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)
  • K923080 — IL TEST APOLIPOROTEIN B (APO B) (October 26, 1992)

FDA data resources