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FDA 510(k)

CDTOX A OIA

K-Number: K991829 · 1999-11-02

ApplicantBiostar, Inc.
Decision Date1999-11-02
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CDTOX A 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 1999-11-02 under 510(k) number K991829. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CDTOX A OIA?

CDTOX A OIA is a medical device that received FDA 510(k) clearance on 1999-11-02. The listed applicant is Biostar, Inc.. The 510(k) number is K991829.

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

CDTOX A OIA received FDA 510(k) clearance on 1999-11-02, under 510(k) number K991829.

Who is the listed applicant for CDTOX A 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 CDTOX A OIA?

The FDA product code for CDTOX A OIA is LLH.

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.

K991828STREP B OIAK981651AB FLU OIAK962060STREP A OIA MAXK951010CHLAMYDIA OIAK936112STREP B OIA

Related Devices (Code: LLH)

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.

K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.K102242OSOM C. DIFFICILE TOXIN A/B TESTGenzyme CorporationK091109XPERT C. DIFFICILECepheidK090239PROGASTRO CD ASSAYProdesse, Inc.K082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, Inc.)

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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