G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE— 510(k) K024006

Name: FDA 510(k) clearance K024006
Creator: U.S. Food and Drug Administration
Published: 2003-03-31

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K024006 for G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE, Substantially Equivalent on 2003-03-31. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code JBF
Device class: Class 2
Regulation: 21 CFR 864.7360
Advisory panel: Hematology
Date received: 2002-12-04
Decision date: 2003-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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K201049 — FINDER G6PD2022-09-14
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K080003 — BINAXNOW G6PD TEST2008-10-23
K933934 — GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A1995-06-29

More clearances from Pointe Scientific, Inc.,

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K070757 — MICROPROTEIN REAGENT SET2007-12-04
K062118 — POINTE 3602007-07-13
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K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR2007-04-13
K070504 — AMMONIA/ALCOHOL CONTROL SET2007-04-11

Recalls naming K024006

K-number listed on FDA's recall record

Z-2487-2015 — Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.Class II·Terminated·Pointe Scientific, Inc.·20150519

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K024006.

Data sourced from openFDA. This site is unofficial and independent of the FDA.