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FDA 510(k)

STREP D FLUOR

K-Number: K860041 · 1986-01-24

ApplicantBio Spec, Inc.
Decision Date1986-01-24
Product CodeGTP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREP D FLUOR is the device name listed in this FDA 510(k) record. The listed applicant is Bio Spec, Inc.. It received FDA 510(k) clearance on 1986-01-24 under 510(k) number K860041. The device is classified under product code GTP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREP D FLUOR?

STREP D FLUOR is a medical device that received FDA 510(k) clearance on 1986-01-24. The listed applicant is Bio Spec, Inc.. The 510(k) number is K860041.

When did STREP D FLUOR receive FDA 510(k) clearance?

STREP D FLUOR received FDA 510(k) clearance on 1986-01-24, under 510(k) number K860041.

Who is the listed applicant for STREP D FLUOR?

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

What is the FDA product code for STREP D FLUOR?

The FDA product code for STREP D FLUOR is GTP.

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 Bio Spec, 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.

K860091BIO SPEC GRAMAFLUOR TEST KITK841479BIO SPEC STREP-A-FLUOR TEST KIT

Related Devices (Code: GTP)

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.

K833738LEAP STREP TEST KITCooper Biomedical, Inc.K822799STREPTACOCCUS CO-AGGLUTINATION KITAmerican Scientific Products

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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