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FDA 510(k)

IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96

K-Number: K031059 · 2003-07-10

ApplicantIvd Research, Inc.
Decision Date2003-07-10
Product CodeMHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 is the device name listed in this FDA 510(k) record. The listed applicant is Ivd Research, Inc.. It received FDA 510(k) clearance on 2003-07-10 under 510(k) number K031059. 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 IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96?

IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 is a medical device that received FDA 510(k) clearance on 2003-07-10. The listed applicant is Ivd Research, Inc.. The 510(k) number is K031059.

When did IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 receive FDA 510(k) clearance?

IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 received FDA 510(k) clearance on 2003-07-10, under 510(k) number K031059.

Who is the listed applicant for IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96?

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

What is the FDA product code for IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96?

The FDA product code for IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 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 Ivd Research, 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.

K081064GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LFK032897C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96K024113IVD CRYPTO/GIARDIA DFAK020583IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

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 BiotechK051929GIARDIA/CRYPTOSPORIDIUM CHEKTechlab, Inc.K052932CRYPTOSPORIDIUM IITechlab, Inc.K031965XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020Remel, Inc.K982764PREMIER CRYPTOSPORIDIUMMeridian Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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