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FDA 510(k)

CELLABS GIARDIA CEL I.F. TEST

K-Number: K912152 · 1991-08-12

ApplicantCelltech Diagnostics , Ltd.
Decision Date1991-08-12
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CELLABS GIARDIA CEL I.F. TEST is the device name listed in this FDA 510(k) record. The listed applicant is Celltech Diagnostics , Ltd.. It received FDA 510(k) clearance on 1991-08-12 under 510(k) number K912152. 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 CELLABS GIARDIA CEL I.F. TEST?

CELLABS GIARDIA CEL I.F. TEST is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Celltech Diagnostics , Ltd.. The 510(k) number is K912152.

When did CELLABS GIARDIA CEL I.F. TEST receive FDA 510(k) clearance?

CELLABS GIARDIA CEL I.F. TEST received FDA 510(k) clearance on 1991-08-12, under 510(k) number K912152.

Who is the listed applicant for CELLABS GIARDIA CEL I.F. TEST?

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

What is the FDA product code for CELLABS GIARDIA CEL I.F. TEST?

The FDA product code for CELLABS GIARDIA CEL I.F. TEST is MHI.

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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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