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FDA 510(k)

E. COLI 0157 LATEX TEST

K-Number: K903714 · 1991-01-24

ApplicantPro-Lab, Inc.
Decision Date1991-01-24
Product CodeGNA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

E. COLI 0157 LATEX TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Lab, Inc.. It received FDA 510(k) clearance on 1991-01-24 under 510(k) number K903714. 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 E. COLI 0157 LATEX TEST?

E. COLI 0157 LATEX TEST is a medical device that received FDA 510(k) clearance on 1991-01-24. The listed applicant is Pro-Lab, Inc.. The 510(k) number is K903714.

When did E. COLI 0157 LATEX TEST receive FDA 510(k) clearance?

E. COLI 0157 LATEX TEST received FDA 510(k) clearance on 1991-01-24, under 510(k) number K903714.

Who is the listed applicant for E. COLI 0157 LATEX TEST?

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

What is the FDA product code for E. COLI 0157 LATEX TEST?

The FDA product code for E. COLI 0157 LATEX TEST is GNA.

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Other records listing Pro-Lab, 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.

K934383PROLEX (STREPTOCCAL GROUPING LATEX KIT)K914419AMNIOTEST(TM)K921421LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYK894221ROSCO PYRRK883996X-ACT LDC/INDK883995X-ACT UREA/TDA

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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.K993401DRYSPOT E.COLI 0157 KITOxoid , Ltd.K981734VTEC-RPLA SEIKENDenka Seiken'SK962028WELLCOLEX E-COLI OI57 ZC60Murex Diagnostics, Inc.K953362PREMIER 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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