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FDA 510(k)

GEMTAB SYSTEM

K-Number: K894503 · 1989-09-05

ApplicantPharmacia Eni Diagnostics, Inc.
Decision Date1989-09-05
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEMTAB SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Eni Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-09-05 under 510(k) number K894503. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMTAB SYSTEM?

GEMTAB SYSTEM is a medical device that received FDA 510(k) clearance on 1989-09-05. The listed applicant is Pharmacia Eni Diagnostics, Inc.. The 510(k) number is K894503.

When did GEMTAB SYSTEM receive FDA 510(k) clearance?

GEMTAB SYSTEM received FDA 510(k) clearance on 1989-09-05, under 510(k) number K894503.

Who is the listed applicant for GEMTAB SYSTEM?

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

What is the FDA product code for GEMTAB SYSTEM?

The FDA product code for GEMTAB SYSTEM is JJQ.

Related Clinical Trials

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Other records listing Pharmacia Eni Diagnostics, Inc. 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.

K897006PHARMACIA MUMPS IGG ELISA

Related Devices (Code: JJQ)

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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