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510(k) K023860

MICROALBUMIN REAGENT SET AND CALIBRATORS by Pointe Scientific, Inc., — Product Code DDZ

K023860 is an FDA 510(k) premarket notification submitted by Pointe Scientific, Inc., for the device "MICROALBUMIN REAGENT SET AND CALIBRATORS". The FDA issued a decision of Substantially Equivalent on April 28, 2003. The device falls under product code DDZ (Albumin, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Pointe Scientific, Inc., has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2003
Date Received
November 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
Review Panel
IM
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)
  • K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (March 28, 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)
  • K024006 — G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (March 31, 2003)

Other clearances for product code DDZ

  • K050576 — MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H (April 21, 2005)
  • K002674 — RANDOX MICROALBUMIN (October 5, 2000)
  • K831902 — FLUORESCEIN CONJUGATED IMMUNOGLOBIN- (July 18, 1983)

FDA data resources