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FDA 510(k)

PHADEBACT MONOCLONAL GC TEST

K-Number: K850351 · 1985-03-13

ApplicantPharmacia, Inc.
Decision Date1985-03-13
Product CodeLIC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHADEBACT MONOCLONAL GC 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 1985-03-13 under 510(k) number K850351. 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 PHADEBACT MONOCLONAL GC TEST?

PHADEBACT MONOCLONAL GC TEST is a medical device that received FDA 510(k) clearance on 1985-03-13. The listed applicant is Pharmacia, Inc.. The 510(k) number is K850351.

When did PHADEBACT MONOCLONAL GC TEST receive FDA 510(k) clearance?

PHADEBACT MONOCLONAL GC TEST received FDA 510(k) clearance on 1985-03-13, under 510(k) number K850351.

Who is the listed applicant for PHADEBACT MONOCLONAL GC 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 MONOCLONAL GC TEST?

The FDA product code for PHADEBACT MONOCLONAL GC TEST is LIC.

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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: 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.K874078MERITEC(TM)-GCMeridian Diagnostics, Inc.K871105THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAENew Horizons Diagnostics Co.K851650PHADEBACT MONOCLONAL GC OMNI 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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