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FDA 510(k)

STREP A OIA MAX

K-Number: K962060 · 1997-07-23

ApplicantBiostar, Inc.
Decision Date1997-07-23
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREP A OIA MAX is the device name listed in this FDA 510(k) record. The listed applicant is Biostar, Inc.. It received FDA 510(k) clearance on 1997-07-23 under 510(k) number K962060. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREP A OIA MAX?

STREP A OIA MAX is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Biostar, Inc.. The 510(k) number is K962060.

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

STREP A OIA MAX received FDA 510(k) clearance on 1997-07-23, under 510(k) number K962060.

Who is the listed applicant for STREP A OIA MAX?

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 A OIA MAX?

The FDA product code for STREP A OIA MAX is GTZ.

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 OIAK951010CHLAMYDIA OIAK936112STREP B OIA

Related Devices (Code: GTZ)

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.

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.K011709UNI-GOLD STREP A TEST KITTrinity Biotech, PlcK010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTBinax, Inc.K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBinax, Inc.K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIAbbott LaboratoriesK962296STREPTOLEX-STATUnipath , Ltd.

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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