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FDA 510(k)

DRYSPOT E.COLI 0157 KIT

K-Number: K993401 · 2000-02-28

ApplicantOxoid , Ltd.
Decision Date2000-02-28
Product CodeGNA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DRYSPOT E.COLI 0157 KIT is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid , Ltd.. It received FDA 510(k) clearance on 2000-02-28 under 510(k) number K993401. The device is classified under product code GNA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRYSPOT E.COLI 0157 KIT?

DRYSPOT E.COLI 0157 KIT is a medical device that received FDA 510(k) clearance on 2000-02-28. The listed applicant is Oxoid , Ltd.. The 510(k) number is K993401.

When did DRYSPOT E.COLI 0157 KIT receive FDA 510(k) clearance?

DRYSPOT E.COLI 0157 KIT received FDA 510(k) clearance on 2000-02-28, under 510(k) number K993401.

Who is the listed applicant for DRYSPOT E.COLI 0157 KIT?

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

What is the FDA product code for DRYSPOT E.COLI 0157 KIT?

The FDA product code for DRYSPOT E.COLI 0157 KIT is GNA.

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Other records listing Oxoid , Ltd. as applicant

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Related Devices (Code: GNA)

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.

K071799MODIFICATION TO BIOSTAR OIA SHIGATOXIverness Medical Professional DiagnosticsK031367DUOPATH VEROTOXINS GLISA TESTEmd Chemicals, Inc.K981734VTEC-RPLA SEIKENDenka Seiken'SK962028WELLCOLEX E-COLI OI57 ZC60Murex Diagnostics, Inc.K953362PREMIER EHECMeridian Diagnostics, Inc.K950167PREMIER EHECMeridian Diagnostics, 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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