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FDA 510(k)

PROSPECT(TM/CRYPTOSPORIDIUM

K-Number: K912242 · 1992-03-23

ApplicantAlexon, Inc.
Decision Date1992-03-23
Product CodeMHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROSPECT(TM/CRYPTOSPORIDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Alexon, Inc.. It received FDA 510(k) clearance on 1992-03-23 under 510(k) number K912242. 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(TM/CRYPTOSPORIDIUM?

PROSPECT(TM/CRYPTOSPORIDIUM is a medical device that received FDA 510(k) clearance on 1992-03-23. The listed applicant is Alexon, Inc.. The 510(k) number is K912242.

When did PROSPECT(TM/CRYPTOSPORIDIUM receive FDA 510(k) clearance?

PROSPECT(TM/CRYPTOSPORIDIUM received FDA 510(k) clearance on 1992-03-23, under 510(k) number K912242.

Who is the listed applicant for PROSPECT(TM/CRYPTOSPORIDIUM?

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

What is the FDA product code for PROSPECT(TM/CRYPTOSPORIDIUM?

The FDA product code for PROSPECT(TM/CRYPTOSPORIDIUM is MHJ.

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Other records listing Alexon, 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.

K934493PROSPECT MICROPLATE ASSAYK942098PROSPECT GIARDIAK931147PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATIONK930451PROSPEC T GIARDIA MICROTITER ASSAYK922675PROSPECT GIARDIA CONTROLSK922010PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION

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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

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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