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FDA 510(k)

125 I-T4 RIA TEST KIT

K-Number: K811070 · 1981-04-29

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1981-04-29
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

125 I-T4 RIA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Immunoassay Laboratories, Inc.. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K811070. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 125 I-T4 RIA TEST KIT?

125 I-T4 RIA TEST KIT is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K811070.

When did 125 I-T4 RIA TEST KIT receive FDA 510(k) clearance?

125 I-T4 RIA TEST KIT received FDA 510(k) clearance on 1981-04-29, under 510(k) number K811070.

Who is the listed applicant for 125 I-T4 RIA TEST KIT?

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

What is the FDA product code for 125 I-T4 RIA TEST KIT?

The FDA product code for 125 I-T4 RIA TEST KIT is CDX.

Other records listing Intl. Immunoassay Laboratories, 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.

K913380MYDAS(TM)-MB2/MYDAS(TM)-MBK913349STAMBI-CKK912231PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KITK903441MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTSK903508LABELLING CHANGES TO IMPRES-MB-XK901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB

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Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter 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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