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FDA 510(k)

PROSPECT CRYPTOSPORIDIUM RAPID ASSAY

K-Number: K936191 · 1994-11-17

ApplicantAlexon Biomedical, Inc.
Decision Date1994-11-17
Product CodeMHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROSPECT CRYPTOSPORIDIUM RAPID ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Alexon Biomedical, Inc.. It received FDA 510(k) clearance on 1994-11-17 under 510(k) number K936191. 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 PROSPECT CRYPTOSPORIDIUM RAPID ASSAY?

PROSPECT CRYPTOSPORIDIUM RAPID ASSAY is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Alexon Biomedical, Inc.. The 510(k) number is K936191.

When did PROSPECT CRYPTOSPORIDIUM RAPID ASSAY receive FDA 510(k) clearance?

PROSPECT CRYPTOSPORIDIUM RAPID ASSAY received FDA 510(k) clearance on 1994-11-17, under 510(k) number K936191.

Who is the listed applicant for PROSPECT CRYPTOSPORIDIUM RAPID ASSAY?

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

What is the FDA product code for PROSPECT CRYPTOSPORIDIUM RAPID ASSAY?

The FDA product code for PROSPECT CRYPTOSPORIDIUM RAPID ASSAY is MHJ.

Related Clinical Trials

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Other records listing Alexon Biomedical, 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.

K964864PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAYK955157PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAYK933997PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAYK874849PROSPECT/GIARDIA

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.K031059IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96Ivd Research, 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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