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FDA 510(k)

GENSTRIP TEST STRIP MODEL 100-201

K-Number: K103542 · 2012-11-30

ApplicantShasta Technologies, LLC
Decision Date2012-11-30
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENSTRIP TEST STRIP MODEL 100-201 is the device name listed in this FDA 510(k) record. The listed applicant is Shasta Technologies, LLC. It received FDA 510(k) clearance on 2012-11-30 under 510(k) number K103542. 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 GENSTRIP TEST STRIP MODEL 100-201?

GENSTRIP TEST STRIP MODEL 100-201 is a medical device that received FDA 510(k) clearance on 2012-11-30. The listed applicant is Shasta Technologies, LLC. The 510(k) number is K103542.

When did GENSTRIP TEST STRIP MODEL 100-201 receive FDA 510(k) clearance?

GENSTRIP TEST STRIP MODEL 100-201 received FDA 510(k) clearance on 2012-11-30, under 510(k) number K103542.

Who is the listed applicant for GENSTRIP TEST STRIP MODEL 100-201?

The FDA 510(k) record lists Shasta Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENSTRIP TEST STRIP MODEL 100-201?

The FDA product code for GENSTRIP TEST STRIP MODEL 100-201 is NBW. This falls under the OB/GYN category.

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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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