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FDA 510(k)

G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE

K-Number: K024006 · 2003-03-31

ApplicantPointe Scientific, Inc.,
Decision Date2003-03-31
Product CodeJBF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 2003-03-31 under 510(k) number K024006. The device is classified under product code JBF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE?

G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE is a medical device that received FDA 510(k) clearance on 2003-03-31. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K024006.

When did G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE receive FDA 510(k) clearance?

G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE received FDA 510(k) clearance on 2003-03-31, under 510(k) number K024006.

Who is the listed applicant for G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE?

The FDA 510(k) record lists Pointe Scientific, Inc., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE?

The FDA product code for G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE is JBF.

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Related Devices (Code: JBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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