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FDA 510(k)

PHADEBACT ETEC-LT TEST

K-Number: K874288 · 1988-09-02

ApplicantPharmacia, Inc.
Decision Date1988-09-02
Product CodeGNA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHADEBACT ETEC-LT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1988-09-02 under 510(k) number K874288. The device is classified under product code GNA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHADEBACT ETEC-LT TEST?

PHADEBACT ETEC-LT TEST is a medical device that received FDA 510(k) clearance on 1988-09-02. The listed applicant is Pharmacia, Inc.. The 510(k) number is K874288.

When did PHADEBACT ETEC-LT TEST receive FDA 510(k) clearance?

PHADEBACT ETEC-LT TEST received FDA 510(k) clearance on 1988-09-02, under 510(k) number K874288.

Who is the listed applicant for PHADEBACT ETEC-LT TEST?

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

What is the FDA product code for PHADEBACT ETEC-LT TEST?

The FDA product code for PHADEBACT ETEC-LT TEST is GNA.

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Other records listing Pharmacia, 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.

K974350ALLERGAN IMMUNO CAP M4, M8, K70K972364UNICAP PHADIATOPK972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMHK962274UNICAP 100

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Related Devices (Code: GNA)

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.

K071799MODIFICATION TO BIOSTAR OIA SHIGATOXIverness Medical Professional DiagnosticsK031367DUOPATH VEROTOXINS GLISA TESTEmd Chemicals, Inc.K993401DRYSPOT E.COLI 0157 KITOxoid , Ltd.K981734VTEC-RPLA SEIKENDenka Seiken'SK962028WELLCOLEX E-COLI OI57 ZC60Murex Diagnostics, Inc.K953362PREMIER EHECMeridian 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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