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FDA 510(k)

OLYMPUS PK-TP SYSTEM REACTIVE CONTROL

K-Number: K894617 · 1989-10-31

ApplicantSchiff & Co.
Decision Date1989-10-31
Product CodeGMI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OLYMPUS PK-TP SYSTEM REACTIVE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Schiff & Co.. It received FDA 510(k) clearance on 1989-10-31 under 510(k) number K894617. The device is classified under product code GMI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS PK-TP SYSTEM REACTIVE CONTROL?

OLYMPUS PK-TP SYSTEM REACTIVE CONTROL is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Schiff & Co.. The 510(k) number is K894617.

When did OLYMPUS PK-TP SYSTEM REACTIVE CONTROL receive FDA 510(k) clearance?

OLYMPUS PK-TP SYSTEM REACTIVE CONTROL received FDA 510(k) clearance on 1989-10-31, under 510(k) number K894617.

Who is the listed applicant for OLYMPUS PK-TP SYSTEM REACTIVE CONTROL?

The FDA 510(k) record lists Schiff & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS PK-TP SYSTEM REACTIVE CONTROL?

The FDA product code for OLYMPUS PK-TP SYSTEM REACTIVE CONTROL is GMI.

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Related Devices (Code: GMI)

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.

K812190COCCIDIOIDES IMMUNODIFFUSION SYSTEMAmerican Scientific ProductsK812185FUNGAL IMMUNODIFFUSION SYSTEMAmerican Scientific ProductsK802129IMMUNODIFFUSION REAGENTS/SEROLOGICALNolan Biological Laboratories, Inc.K792716CANDIDA ALBICANS, ANTIGENMeridian Diagnostics, Inc.K792713CANDIDA ALBICANS, ANTISERUMMeridian Diagnostics, Inc.K792682COCCIDIOIDES IMMITIS, ANTIGENMeridian Diagnostics, 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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