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FDA 510(k)

CHLAMYDIA OIA

K-Number: K951010 · 1995-10-07

ApplicantBiostar, Inc.
Decision Date1995-10-07
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIA 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 1995-10-07 under 510(k) number K951010. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLAMYDIA OIA?

CHLAMYDIA OIA is a medical device that received FDA 510(k) clearance on 1995-10-07. The listed applicant is Biostar, Inc.. The 510(k) number is K951010.

When did CHLAMYDIA OIA receive FDA 510(k) clearance?

CHLAMYDIA OIA received FDA 510(k) clearance on 1995-10-07, under 510(k) number K951010.

Who is the listed applicant for CHLAMYDIA 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 CHLAMYDIA OIA?

The FDA product code for CHLAMYDIA OIA is LJC.

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.

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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 MAXK936112STREP B OIA

Related Devices (Code: LJC)

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.

K032330CT OIAThermo Biostar, Inc.K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.K033079CHLAMYDIA IGG ELISA TEST SYSTEMTrinity Biotech USAK982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLCK960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, 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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