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510(k) K024006

G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE by Pointe Scientific, Inc., — Product Code JBF

K024006 is an FDA 510(k) premarket notification submitted by Pointe Scientific, Inc., for the device "G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE". The FDA issued a decision of Substantially Equivalent on March 31, 2003. The device falls under product code JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening), a Class II device regulated under 21 CFR 864.7360. Pointe Scientific, Inc., has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2003
Date Received
December 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Device Class
Class II
Regulation Number
864.7360
Review Panel
HE
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)
  • K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS (April 28, 2003)

Other clearances for product code JBF

  • K201049 — FINDER G6PD (September 14, 2022)
  • K161364 — BinaxNOW G6PD Test (June 17, 2016)
  • K080003 — BINAXNOW G6PD TEST (October 23, 2008)
  • K933934 — GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A (June 29, 1995)

FDA data resources