FDA 510(k)

GC-TECT

K-Number: K840159 · 1984-01-30

Decision Date1984-01-30

Product CodeJTY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

GC-TECT is the device name listed in this FDA 510(k) record. The listed applicant is Uti-Tect, Inc.. It received FDA 510(k) clearance on 1984-01-30 under 510(k) number K840159. The device is classified under product code JTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC-TECT?

GC-TECT is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is Uti-Tect, Inc.. The 510(k) number is K840159.

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

GC-TECT received FDA 510(k) clearance on 1984-01-30, under 510(k) number K840159.

Who is the listed applicant for GC-TECT?

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

What is the FDA product code for GC-TECT?

The FDA product code for GC-TECT is JTY.

Other records listing Uti-Tect, 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.

K840160B-STREP-TECT-II K812581SENSI-TECT

Related Devices (Code: JTY)

K210511InTray GCBiomed Diagnostics Incorporated K993033INTRAY GCBiomed Diagnostics, Inc.K954986GC BASE W/ 1% GCHIRemel, L.P.K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIABioclinical Systems, Inc.K933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARBioclinical Systems, Inc.K933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARBioclinical Systems, 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.