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FDA 510(k)

125 I-T4 RIA REAGENT

K-Number: K780672 · 1978-06-06

ApplicantRadioimmunoassay, Inc.
Decision Date1978-06-06
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

125 I-T4 RIA REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Radioimmunoassay, Inc.. It received FDA 510(k) clearance on 1978-06-06 under 510(k) number K780672. 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 REAGENT?

125 I-T4 RIA REAGENT is a medical device that received FDA 510(k) clearance on 1978-06-06. The listed applicant is Radioimmunoassay, Inc.. The 510(k) number is K780672.

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

125 I-T4 RIA REAGENT received FDA 510(k) clearance on 1978-06-06, under 510(k) number K780672.

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

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

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

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

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Other records listing Radioimmunoassay, Inc. as applicant

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K802135TESTOSTERONE RADIOIMMUNOASSY KITK800106LUTEINIZING HORMONE RADIOIMMUNOASSAY SYSK800107FOLLICLE STIMULATING HORMONEK792539TRIIODOTHYRONINE RIA SYSTEMK792153DIGOXIN RADIOIMMUNOASSAY SYSTEMK792154THYROID STIMULATING HORMONE

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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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