510(k) K864393

APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC by Intl. Diagnostic Laboratories, Ltd. — Product Code MSJ

K864393 is an FDA 510(k) premarket notification submitted by Intl. Diagnostic Laboratories, Ltd. for the device "APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC". The FDA issued a decision of Substantially Equivalent on January 16, 1987. The device falls under product code MSJ (Apolipoproteins), a Class I device regulated under 21 CFR 862.1475. Intl. Diagnostic Laboratories, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 16, 1987
Date Received: November 6, 1986
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 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)
K923087 — IL TEST APOLIPOPROTEIN A1 (October 26, 1992)

510(k) K864393

Clearance Details

Device Classification

Other clearances by Intl. Diagnostic Laboratories, Ltd.

Other clearances for product code MSJ

FDA data resources