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FDA 510(k)

125I ESTRADIOL DIRECT RADIOIMMUNOASSAY

K-Number: K853208 · 1985-08-19

ApplicantTravenol Laboratories, S.A.
Decision Date1985-08-19
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

125I ESTRADIOL DIRECT RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1985-08-19 under 510(k) number K853208. The device is classified under product code CHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY?

125I ESTRADIOL DIRECT RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1985-08-19. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K853208.

When did 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY receive FDA 510(k) clearance?

125I ESTRADIOL DIRECT RADIOIMMUNOASSAY received FDA 510(k) clearance on 1985-08-19, under 510(k) number K853208.

Who is the listed applicant for 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY?

The FDA product code for 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY is CHP.

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Other records listing Travenol Laboratories, S.A. as applicant

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Related Devices (Code: CHP)

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.

K041349LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMIbl GmbHK97390117 B-ESTRADIOL (ELISA)Kmi Diagnostics, Inc.K973743ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc.K970386ACS ESTADIOL-6 IIChiron Diagnostics Corp.K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)Johnson & Johnson Clinical Diagnostics, Inc.K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)Bio-Rad Laboratories, 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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