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FDA 510(k)

GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK

K-Number: K103673 · 2011-08-18

ApplicantTechlab Inc., Corporate Research Center
Decision Date2011-08-18
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK is the device name listed in this FDA 510(k) record. The listed applicant is Techlab Inc., Corporate Research Center. It received FDA 510(k) clearance on 2011-08-18 under 510(k) number K103673. The device is classified under product code MHI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK?

GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK is a medical device that received FDA 510(k) clearance on 2011-08-18. The listed applicant is Techlab Inc., Corporate Research Center. The 510(k) number is K103673.

When did GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK receive FDA 510(k) clearance?

GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK received FDA 510(k) clearance on 2011-08-18, under 510(k) number K103673.

Who is the listed applicant for GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK?

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

What is the FDA product code for GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK?

The FDA product code for GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK is MHI.

Related Clinical Trials

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Other records listing Techlab Inc., Corporate Research Center 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.

K121364SHIGA TOXIN QUIK CHEKK121411SHIGA TOXIN CHEKK071712LEUKO EZ VUEK071711ASCA-CHEK

Related Devices (Code: MHI)

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.

K120001UNIGOLD GIARDIATrinity BiotechK081064GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LFIvd Research, Inc.K031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020Remel, Inc.K031834XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAYRemel, Inc.K033274GIARDIA IITechlab, Inc.K024113IVD CRYPTO/GIARDIA DFAIvd Research, 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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