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FDA 510(k)

SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K093764 · 2010-03-02

ApplicantBiotest Medical Corp.
Decision Date2010-03-02
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM 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 2010-03-02 under 510(k) number K093764. 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 SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM?

SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-02. The listed applicant is Biotest Medical Corp.. The 510(k) number is K093764.

When did SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2010-03-02, under 510(k) number K093764.

Who is the listed applicant for SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM?

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 SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM 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 SYSTEMK100560EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277K100701SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277K091815SUPERCHECK 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.

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes CareK262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

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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