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FDA 510(k)

C. DIFF CHEK - 60

K-Number: K030992 · 2003-07-11

ApplicantTechlab, Inc.
Decision Date2003-07-11
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

C. DIFF CHEK - 60 is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2003-07-11 under 510(k) number K030992. 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 C. DIFF CHEK - 60?

C. DIFF CHEK - 60 is a medical device that received FDA 510(k) clearance on 2003-07-11. The listed applicant is Techlab, Inc.. The 510(k) number is K030992.

When did C. DIFF CHEK - 60 receive FDA 510(k) clearance?

C. DIFF CHEK - 60 received FDA 510(k) clearance on 2003-07-11, under 510(k) number K030992.

Who is the listed applicant for C. DIFF CHEK - 60?

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

What is the FDA product code for C. DIFF CHEK - 60?

The FDA product code for C. DIFF CHEK - 60 is LLH.

Other records listing Techlab, Inc. as applicant

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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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