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FDA 510(k)

GC BASE W/ 1% GCHI

K-Number: K954986 · 1996-02-16

ApplicantRemel, L.P.
Decision Date1996-02-16
Product CodeJTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GC BASE W/ 1% GCHI is the device name listed in this FDA 510(k) record. The listed applicant is Remel, L.P.. It received FDA 510(k) clearance on 1996-02-16 under 510(k) number K954986. 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 BASE W/ 1% GCHI?

GC BASE W/ 1% GCHI is a medical device that received FDA 510(k) clearance on 1996-02-16. The listed applicant is Remel, L.P.. The 510(k) number is K954986.

When did GC BASE W/ 1% GCHI receive FDA 510(k) clearance?

GC BASE W/ 1% GCHI received FDA 510(k) clearance on 1996-02-16, under 510(k) number K954986.

Who is the listed applicant for GC BASE W/ 1% GCHI?

The FDA 510(k) record lists Remel, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GC BASE W/ 1% GCHI?

The FDA product code for GC BASE W/ 1% GCHI is JTY.

Other records listing Remel, L.P. 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.

K972359REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCINK964315REMEL STAPH LATEX KITK964421REMEL MEROPENEM 10UG SUSCEPTIBILITY DISKK96104610B ARGININE BROTHK955143RPR LIQUID CONTROLSK955136RPR CARD TEST KIT

View all 10 devices →

Related Devices (Code: JTY)

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.

K210511InTray GCBiomed Diagnostics IncorporatedK993033INTRAY GCBiomed Diagnostics, Inc.K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIABioclinical Systems, Inc.K933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARBioclinical Systems, Inc.K933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARBioclinical Systems, Inc.K934331THAYER MARTIN, MODIFIED PILL POCKETHardy Diagnostics

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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