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FDA 510(k)

UNI-GOLD CRYPTOSPORIDIUM

K-Number: K121565 · 2013-02-08

ApplicantTrinity Biotech
Decision Date2013-02-08
Product CodeMHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

UNI-GOLD CRYPTOSPORIDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Biotech. It received FDA 510(k) clearance on 2013-02-08 under 510(k) number K121565. The device is classified under product code MHJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-GOLD CRYPTOSPORIDIUM?

UNI-GOLD CRYPTOSPORIDIUM is a medical device that received FDA 510(k) clearance on 2013-02-08. The listed applicant is Trinity Biotech. The 510(k) number is K121565.

When did UNI-GOLD CRYPTOSPORIDIUM receive FDA 510(k) clearance?

UNI-GOLD CRYPTOSPORIDIUM received FDA 510(k) clearance on 2013-02-08, under 510(k) number K121565.

Who is the listed applicant for UNI-GOLD CRYPTOSPORIDIUM?

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

What is the FDA product code for UNI-GOLD CRYPTOSPORIDIUM?

The FDA product code for UNI-GOLD CRYPTOSPORIDIUM is MHJ.

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Other records listing Trinity Biotech 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.

K172254Lyme B. burgdorferi (IgM) MarStripe TestK163095Lyme B. burgdorferi (IgG) MarStripe TestK120001UNIGOLD GIARDIAK083896DESTINY MAX COAGULATION ANALYZER

Related Devices (Code: MHJ)

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.

K171078TRI-COMBO PARASITE SCREENTechlab, Inc.K051929GIARDIA/CRYPTOSPORIDIUM CHEKTechlab, Inc.K052932CRYPTOSPORIDIUM IITechlab, Inc.K031965XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020Remel, Inc.K031059IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96Ivd Research, Inc.K982764PREMIER CRYPTOSPORIDIUMMeridian 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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