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FDA 510(k)

XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020

K-Number: K031965 · 2003-11-14

ApplicantRemel, Inc.
Decision Date2003-11-14
Product CodeMHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 2003-11-14 under 510(k) number K031965. 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 XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020?

XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 is a medical device that received FDA 510(k) clearance on 2003-11-14. The listed applicant is Remel, Inc.. The 510(k) number is K031965.

When did XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 receive FDA 510(k) clearance?

XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 received FDA 510(k) clearance on 2003-11-14, under 510(k) number K031965.

Who is the listed applicant for XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020?

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

What is the FDA product code for XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020?

The FDA product code for XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 is MHJ.

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Other records listing Remel, 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.

K162620Remel Spectra ESBLK131804REMEL XPECT FLU A&BK092407REMEL SPECTRA MRSAK072827RPMI 1640 AGAR W/MOPS AND 2% GLUCOSEK041951XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BK033479PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY

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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.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.

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