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FDA 510(k)

MERITEC(TM)-GC

K-Number: K874078 · 1987-12-09

ApplicantMeridian Diagnostics, Inc.
Decision Date1987-12-09
Product CodeLIC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MERITEC(TM)-GC is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-12-09 under 510(k) number K874078. The device is classified under product code LIC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERITEC(TM)-GC?

MERITEC(TM)-GC is a medical device that received FDA 510(k) clearance on 1987-12-09. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K874078.

When did MERITEC(TM)-GC receive FDA 510(k) clearance?

MERITEC(TM)-GC received FDA 510(k) clearance on 1987-12-09, under 510(k) number K874078.

Who is the listed applicant for MERITEC(TM)-GC?

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

What is the FDA product code for MERITEC(TM)-GC?

The FDA product code for MERITEC(TM)-GC is LIC.

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Other records listing Meridian Diagnostics, Inc. as applicant

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Related Devices (Code: LIC)

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.

K921075PHADEBACT MONOCLONAL GC TEST, MODIFICATIONKaro Bio Diagnostics ABK911430IDEIA(TM) CHLAMYDIA, MODIFICATIONNovo Nordisk Diagnostics, Ltd.K880076G-MARKBainbridge Laboratories, Inc.K871105THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAENew Horizons Diagnostics Co.K851650PHADEBACT MONOCLONAL GC OMNI TESTPharmacia, Inc.K850351PHADEBACT MONOCLONAL GC TESTPharmacia, 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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