FDA 510(k)

SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268

K-Number: K091815 · 2009-11-16

Decision Date2009-11-16

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 is the device name listed in this FDA 510(k) record. The listed applicant is Biotest Medical Corp.. It received FDA 510(k) clearance on 2009-11-16 under 510(k) number K091815. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268?

SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 is a medical device that received FDA 510(k) clearance on 2009-11-16. The listed applicant is Biotest Medical Corp.. The 510(k) number is K091815.

When did SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 receive FDA 510(k) clearance?

SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 received FDA 510(k) clearance on 2009-11-16, under 510(k) number K091815.

Who is the listed applicant for SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268?

The FDA 510(k) record lists Biotest Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268?

The FDA product code for SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 is NBW. This falls under the OB/GYN category.

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Other records listing Biotest Medical Corp. as applicant

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Official Source

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