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FDA 510(k)

ANTI-TPO

K-Number: K954256 · 1995-11-27

ApplicantBiomerica, Inc.
Decision Date1995-11-27
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-TPO is the device name listed in this FDA 510(k) record. The listed applicant is Biomerica, Inc.. It received FDA 510(k) clearance on 1995-11-27 under 510(k) number K954256. The device is classified under product code JNL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-TPO?

ANTI-TPO is a medical device that received FDA 510(k) clearance on 1995-11-27. The listed applicant is Biomerica, Inc.. The 510(k) number is K954256.

When did ANTI-TPO receive FDA 510(k) clearance?

ANTI-TPO received FDA 510(k) clearance on 1995-11-27, under 510(k) number K954256.

Who is the listed applicant for ANTI-TPO?

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

What is the FDA product code for ANTI-TPO?

The FDA product code for ANTI-TPO is JNL.

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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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