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FDA 510(k)

OLYMPUS PK(TM) TP

K-Number: K893124 · 1989-11-17

ApplicantFujirebio Diagnostics,Inc.
Decision Date1989-11-17
Product CodeGMT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OLYMPUS PK(TM) TP is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 1989-11-17 under 510(k) number K893124. 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 OLYMPUS PK(TM) TP?

OLYMPUS PK(TM) TP is a medical device that received FDA 510(k) clearance on 1989-11-17. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K893124.

When did OLYMPUS PK(TM) TP receive FDA 510(k) clearance?

OLYMPUS PK(TM) TP received FDA 510(k) clearance on 1989-11-17, under 510(k) number K893124.

Who is the listed applicant for OLYMPUS PK(TM) TP?

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

What is the FDA product code for OLYMPUS PK(TM) TP?

The FDA product code for OLYMPUS PK(TM) TP is GMT.

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Other records listing Fujirebio Diagnostics,Inc. as applicant

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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.

K971502SERODIA TP-PAScimedx Tekfile ServicesK911640OLYMPUS PK TP(TM) SYSTEM, MODIFICATIONOlympus Corp.K911266MODIFIED PK TP CONTROLOlympus Corp.K905038OLYMPUS PK-TP ABSORBENT KITFujirebio America, Inc.K896410CELLOGNOST SYPHILIS HBehring Diagnostics, Inc.K791897BACTO-HATTSDifco Laboratories, Inc.

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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