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FDA 510(k)

IMX T3 ASSAY

K-Number: K944808 · 1994-12-09

ApplicantOrganon Teknika Corp.
Decision Date1994-12-09
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMX T3 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1994-12-09 under 510(k) number K944808. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMX T3 ASSAY?

IMX T3 ASSAY is a medical device that received FDA 510(k) clearance on 1994-12-09. The listed applicant is Organon Teknika Corp.. The 510(k) number is K944808.

When did IMX T3 ASSAY receive FDA 510(k) clearance?

IMX T3 ASSAY received FDA 510(k) clearance on 1994-12-09, under 510(k) number K944808.

Who is the listed applicant for IMX T3 ASSAY?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMX T3 ASSAY?

The FDA product code for IMX T3 ASSAY is CDP.

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Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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