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510(k) K861882

IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B by Orion Corp. — Product Code MSJ

K861882 is an FDA 510(k) premarket notification submitted by Orion Corp. for the device "IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B". The FDA issued a decision of Substantially Equivalent on October 29, 1986. The device falls under product code MSJ (Apolipoproteins), a Class I device regulated under 21 CFR 862.1475. Orion Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1986
Date Received
May 15, 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 by Orion Corp.

  • K912391 — RUBALEX, MODIFICATION (May 4, 1992)
  • K901637 — RESUBMITTED MODIFIED RUBALEX (April 26, 1990)
  • K884650 — RESUBMITTED SCANORA (March 16, 1989)
  • K890199 — DENTOCULT SM-STRIP MUTANS (March 2, 1989)
  • K881505 — MAMEX DC MG11 (June 10, 1988)
  • K881506 — MAMEX DC MAG MG12 (June 10, 1988)
  • K874040 — MAMEX DC S SL10/MG14 (November 23, 1987)
  • K872744 — MODIFIED CHLAMYSET ANTIGEN (September 22, 1987)
  • K872301 — DENTOCULT-SM CULTURE-PADDLE (September 11, 1987)
  • K864457 — CHLAMYSET ANTIBODY EIA (September 11, 1987)

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)

FDA data resources