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FDA 510(k)

SERODIA TP-PA

K-Number: K971502 · 1997-11-13

ApplicantScimedx Tekfile Services
Decision Date1997-11-13
Product CodeGMT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERODIA TP-PA is the device name listed in this FDA 510(k) record. The listed applicant is Scimedx Tekfile Services. It received FDA 510(k) clearance on 1997-11-13 under 510(k) number K971502. The device is classified under product code GMT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERODIA TP-PA?

SERODIA TP-PA is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is Scimedx Tekfile Services. The 510(k) number is K971502.

When did SERODIA TP-PA receive FDA 510(k) clearance?

SERODIA TP-PA received FDA 510(k) clearance on 1997-11-13, under 510(k) number K971502.

Who is the listed applicant for SERODIA TP-PA?

The FDA 510(k) record lists Scimedx Tekfile Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERODIA TP-PA?

The FDA product code for SERODIA TP-PA is GMT.

Related Clinical Trials

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Related Devices (Code: GMT)

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.

K911640OLYMPUS PK TP(TM) SYSTEM, MODIFICATIONOlympus Corp.K911266MODIFIED PK TP CONTROLOlympus Corp.K905038OLYMPUS PK-TP ABSORBENT KITFujirebio America, Inc.K896410CELLOGNOST SYPHILIS HBehring Diagnostics, Inc.K893124OLYMPUS PK(TM) TPFujirebio Diagnostics,Inc.K791897BACTO-HATTSDifco Laboratories, Inc.

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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