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FDA 510(k)

MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY

K-Number: K982709 · 1998-09-03

ApplicantAlexon - Trend, Inc.
Decision Date1998-09-03
Product CodeMHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Alexon - Trend, Inc.. It received FDA 510(k) clearance on 1998-09-03 under 510(k) number K982709. 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 MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY?

MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY is a medical device that received FDA 510(k) clearance on 1998-09-03. The listed applicant is Alexon - Trend, Inc.. The 510(k) number is K982709.

When did MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY receive FDA 510(k) clearance?

MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY received FDA 510(k) clearance on 1998-09-03, under 510(k) number K982709.

Who is the listed applicant for MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY?

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

What is the FDA product code for MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY?

The FDA product code for MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY is MHJ.

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Other records listing Alexon - Trend, 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.

K982315PROSPECT CAMPYLOBACTER MICROPLATE ASSAYK980507PROSPECT SHIGA TOXIN MICROPLATE ASSAY

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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