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FDA 510(k)

INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC

K-Number: K051638 · 2005-12-06

ApplicantUnipath , Ltd.
Decision Date2005-12-06
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 2005-12-06 under 510(k) number K051638. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC?

INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC is a medical device that received FDA 510(k) clearance on 2005-12-06. The listed applicant is Unipath , Ltd.. The 510(k) number is K051638.

When did INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC receive FDA 510(k) clearance?

INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC received FDA 510(k) clearance on 2005-12-06, under 510(k) number K051638.

Who is the listed applicant for INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC?

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

What is the FDA product code for INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC?

The FDA product code for INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC is GTY.

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Related Devices (Code: GTY)

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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