Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GIARDIA/CRYPTOSPORIDIUM CHEK

K-Number: K051929 · 2005-11-17

ApplicantTechlab, Inc.
Decision Date2005-11-17
Product CodeMHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GIARDIA/CRYPTOSPORIDIUM CHEK is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2005-11-17 under 510(k) number K051929. 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 GIARDIA/CRYPTOSPORIDIUM CHEK?

GIARDIA/CRYPTOSPORIDIUM CHEK is a medical device that received FDA 510(k) clearance on 2005-11-17. The listed applicant is Techlab, Inc.. The 510(k) number is K051929.

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

GIARDIA/CRYPTOSPORIDIUM CHEK received FDA 510(k) clearance on 2005-11-17, under 510(k) number K051929.

Who is the listed applicant for GIARDIA/CRYPTOSPORIDIUM CHEK?

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 GIARDIA/CRYPTOSPORIDIUM CHEK?

The FDA product code for GIARDIA/CRYPTOSPORIDIUM CHEK is MHJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Techlab, 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.

K191442Campylobacter ChekK191456Campylobacter Quik ChekK181400H. PYLORI CHEK™K181379H. PYLORI QUIK CHEKK173217CAMPYLOBACTER QUIK CHEKK173219CAMPYLOBACTER CHEK

View all 36 devices →

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.K121565UNI-GOLD CRYPTOSPORIDIUMTrinity BiotechK052932CRYPTOSPORIDIUM 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.

↑