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FDA 510(k)

ESTRADIOL DIRECT RIA KIT

K-Number: K851540 · 1985-06-06

ApplicantBiotecx Laboratories, Inc.
Decision Date1985-06-06
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESTRADIOL DIRECT RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biotecx Laboratories, Inc.. It received FDA 510(k) clearance on 1985-06-06 under 510(k) number K851540. 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 ESTRADIOL DIRECT RIA KIT?

ESTRADIOL DIRECT RIA KIT is a medical device that received FDA 510(k) clearance on 1985-06-06. The listed applicant is Biotecx Laboratories, Inc.. The 510(k) number is K851540.

When did ESTRADIOL DIRECT RIA KIT receive FDA 510(k) clearance?

ESTRADIOL DIRECT RIA KIT received FDA 510(k) clearance on 1985-06-06, under 510(k) number K851540.

Who is the listed applicant for ESTRADIOL DIRECT RIA KIT?

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

What is the FDA product code for ESTRADIOL DIRECT RIA KIT?

The FDA product code for ESTRADIOL DIRECT RIA KIT is CHP.

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Other records listing Biotecx 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.

K982298OPTICOAT T4 EIA KITK981824OPTICOAT T3 EIA KITK895407CORTISOL CLASP-BEAD EIA KITK893620T3 CLASP-BEAD EIA KITK892853T4 CLASP-BEAD EIA KITK883765TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE

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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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