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FDA 510(k)

PHADEBACT MONOCLONAL GC TEST, MODIFICATION

K-Number: K921075 · 1992-05-22

ApplicantKaro Bio Diagnostics AB
Decision Date1992-05-22
Product CodeLIC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHADEBACT MONOCLONAL GC TEST, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Karo Bio Diagnostics AB. It received FDA 510(k) clearance on 1992-05-22 under 510(k) number K921075. 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, MODIFICATION?

PHADEBACT MONOCLONAL GC TEST, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-05-22. The listed applicant is Karo Bio Diagnostics AB. The 510(k) number is K921075.

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

PHADEBACT MONOCLONAL GC TEST, MODIFICATION received FDA 510(k) clearance on 1992-05-22, under 510(k) number K921075.

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

The FDA 510(k) record lists Karo Bio Diagnostics AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHADEBACT MONOCLONAL GC TEST, MODIFICATION?

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

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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.

K911430IDEIA(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.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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