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FDA 510(k)

EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277

K-Number: K100560 · 2010-05-12

ApplicantBiotest Medical Corp.
Decision Date2010-05-12
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 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 2010-05-12 under 510(k) number K100560. 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 EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277?

EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 is a medical device that received FDA 510(k) clearance on 2010-05-12. The listed applicant is Biotest Medical Corp.. The 510(k) number is K100560.

When did EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 receive FDA 510(k) clearance?

EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 received FDA 510(k) clearance on 2010-05-12, under 510(k) number K100560.

Who is the listed applicant for EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277?

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 EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277?

The FDA product code for EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 is NBW. This falls under the OB/GYN category.

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Other records listing Biotest Medical Corp. as applicant

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.

K123559SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEMK122525SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEMK100701SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277K093764SOLOV2 BLOOD GLUCOSE MONITORING SYSTEMK091815SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268

Related Devices (Code: NBW)

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

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

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