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FDA 510(k)

PROGASTRO CD ASSAY

K-Number: K090239 · 2009-04-16

ApplicantProdesse, Inc.
Decision Date2009-04-16
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROGASTRO CD ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Prodesse, Inc.. It received FDA 510(k) clearance on 2009-04-16 under 510(k) number K090239. 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 PROGASTRO CD ASSAY?

PROGASTRO CD ASSAY is a medical device that received FDA 510(k) clearance on 2009-04-16. The listed applicant is Prodesse, Inc.. The 510(k) number is K090239.

When did PROGASTRO CD ASSAY receive FDA 510(k) clearance?

PROGASTRO CD ASSAY received FDA 510(k) clearance on 2009-04-16, under 510(k) number K090239.

Who is the listed applicant for PROGASTRO CD ASSAY?

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

What is the FDA product code for PROGASTRO CD ASSAY?

The FDA product code for PROGASTRO CD ASSAY 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 Prodesse, 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.

K091053PROPARAFLU+ASSAYK092500MODIFICATION TO PROFLU+ ASSAYK082688PRO HMPV+ ASSAYK081030MODIFICATION TO PROFLU+ ASSAYK073029PROFLU+ ASSAY

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. DIFFICILECepheidK082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, Inc.)K080931VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAYbioMerieux, 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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