Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STREP B OIA

K-Number: K936112 · 1994-07-06

ApplicantBiostar, Inc.
Decision Date1994-07-06
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREP B OIA is the device name listed in this FDA 510(k) record. The listed applicant is Biostar, Inc.. It received FDA 510(k) clearance on 1994-07-06 under 510(k) number K936112. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREP B OIA?

STREP B OIA is a medical device that received FDA 510(k) clearance on 1994-07-06. The listed applicant is Biostar, Inc.. The 510(k) number is K936112.

When did STREP B OIA receive FDA 510(k) clearance?

STREP B OIA received FDA 510(k) clearance on 1994-07-06, under 510(k) number K936112.

Who is the listed applicant for STREP B OIA?

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

What is the FDA product code for STREP B OIA?

The FDA product code for STREP B OIA is GTY.

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 Biostar, 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.

K991829CDTOX A OIAK991828STREP B OIAK981651AB FLU OIAK962060STREP A OIA MAXK951010CHLAMYDIA OIA

Related Devices (Code: GTY)

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.

K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripACON Laboratories, Inc.K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLCK171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel CorporationK123793SOFIA STREP A FIAQuidel CorporationK122718BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREPBecton, Dickinson and Company

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.

↑