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FDA 510(k)

MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA

K-Number: K912408 · 1991-07-24

ApplicantMeridian Diagnostics, Inc.
Decision Date1991-07-24
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-07-24 under 510(k) number K912408. The device is classified under product code MHI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA?

MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K912408.

When did MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA receive FDA 510(k) clearance?

MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA received FDA 510(k) clearance on 1991-07-24, under 510(k) number K912408.

Who is the listed applicant for MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA?

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

What is the FDA product code for MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA?

The FDA product code for MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA is MHI.

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Other records listing Meridian Diagnostics, 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.

K993914PREMIER TOXINS A&B, MODEL 616096K990263IMMUNOCARD STAT! E. COLI O157:H7K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUM

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Related Devices (Code: MHI)

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.

K120001UNIGOLD GIARDIATrinity BiotechK103673GIARDIA/ CRYPTOSPORIDIUM QUIK CHEKTechlab Inc., Corporate Research CenterK081064GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LFIvd Research, Inc.K031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020Remel, Inc.K031834XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAYRemel, Inc.K033274GIARDIA IITechlab, 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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