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510(k) K061377

APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS by Pointe Scientific, Inc., — Product Code MSJ

K061377 is an FDA 510(k) premarket notification submitted by Pointe Scientific, Inc., for the device "APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS". The FDA issued a decision of Substantially Equivalent on March 28, 2007. The device falls under product code MSJ (Apolipoproteins), a Class I device regulated under 21 CFR 862.1475. Pointe Scientific, Inc., has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2007
Date Received
May 17, 2006
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 Pointe Scientific, Inc.,

  • K070757 — MICROPROTEIN REAGENT SET (December 4, 2007)
  • K062118 — POINTE 360 (July 13, 2007)
  • K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT (April 30, 2007)
  • K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR (April 13, 2007)
  • K070504 — AMMONIA/ALCOHOL CONTROL SET (April 11, 2007)
  • K051646 — ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH (October 7, 2005)
  • K040391 — TOTAL BILIRUBIN REAGENT SET (June 2, 2004)
  • K031539 — HEMOGLOBIN A1C REAGENT SET (August 6, 2003)
  • K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS (April 28, 2003)
  • K024006 — G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (March 31, 2003)

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)
  • 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