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FDA 510(k)

FLUORESCENT ANTIBODY CONJUGATE FOR GP.A

K-Number: K812013 · 1981-07-28

ApplicantSpringwood Microbiologicals
Decision Date1981-07-28
Product CodeGTX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FLUORESCENT ANTIBODY CONJUGATE FOR GP.A is the device name listed in this FDA 510(k) record. The listed applicant is Springwood Microbiologicals. It received FDA 510(k) clearance on 1981-07-28 under 510(k) number K812013. The device is classified under product code GTX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORESCENT ANTIBODY CONJUGATE FOR GP.A?

FLUORESCENT ANTIBODY CONJUGATE FOR GP.A is a medical device that received FDA 510(k) clearance on 1981-07-28. The listed applicant is Springwood Microbiologicals. The 510(k) number is K812013.

When did FLUORESCENT ANTIBODY CONJUGATE FOR GP.A receive FDA 510(k) clearance?

FLUORESCENT ANTIBODY CONJUGATE FOR GP.A received FDA 510(k) clearance on 1981-07-28, under 510(k) number K812013.

Who is the listed applicant for FLUORESCENT ANTIBODY CONJUGATE FOR GP.A?

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

What is the FDA product code for FLUORESCENT ANTIBODY CONJUGATE FOR GP.A?

The FDA product code for FLUORESCENT ANTIBODY CONJUGATE FOR GP.A is GTX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Springwood Microbiologicals 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.

K813339DIRECT FA CONJUGATE FOR LEGIONELLA SP

Related Devices (Code: GTX)

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.

K801876STREP B POLYVALENT FLUORO-KITClinical Sciences, 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.

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