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FDA 510(k)

TREP-SURE TREPONEMAL ANTIBODY EIA

K-Number: K053570 · 2006-08-07

ApplicantPhoenix Biotech Corp.
Decision Date2006-08-07
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TREP-SURE TREPONEMAL ANTIBODY EIA is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Biotech Corp.. It received FDA 510(k) clearance on 2006-08-07 under 510(k) number K053570. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TREP-SURE TREPONEMAL ANTIBODY EIA?

TREP-SURE TREPONEMAL ANTIBODY EIA is a medical device that received FDA 510(k) clearance on 2006-08-07. The listed applicant is Phoenix Biotech Corp.. The 510(k) number is K053570.

When did TREP-SURE TREPONEMAL ANTIBODY EIA receive FDA 510(k) clearance?

TREP-SURE TREPONEMAL ANTIBODY EIA received FDA 510(k) clearance on 2006-08-07, under 510(k) number K053570.

Who is the listed applicant for TREP-SURE TREPONEMAL ANTIBODY EIA?

The FDA 510(k) record lists Phoenix Biotech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TREP-SURE TREPONEMAL ANTIBODY EIA?

The FDA product code for TREP-SURE TREPONEMAL ANTIBODY EIA is LIP.

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Other records listing Phoenix Biotech 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.

K001552TREPCHEK TREPONEMAL ANTIBODY EIA

Related Devices (Code: LIP)

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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