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FDA 510(k)

17 B-ESTRADIOL (ELISA)

K-Number: K973901 · 1997-11-24

ApplicantKmi Diagnostics, Inc.
Decision Date1997-11-24
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

17 B-ESTRADIOL (ELISA) is the device name listed in this FDA 510(k) record. The listed applicant is Kmi Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-11-24 under 510(k) number K973901. 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 17 B-ESTRADIOL (ELISA)?

17 B-ESTRADIOL (ELISA) is a medical device that received FDA 510(k) clearance on 1997-11-24. The listed applicant is Kmi Diagnostics, Inc.. The 510(k) number is K973901.

When did 17 B-ESTRADIOL (ELISA) receive FDA 510(k) clearance?

17 B-ESTRADIOL (ELISA) received FDA 510(k) clearance on 1997-11-24, under 510(k) number K973901.

Who is the listed applicant for 17 B-ESTRADIOL (ELISA)?

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

What is the FDA product code for 17 B-ESTRADIOL (ELISA)?

The FDA product code for 17 B-ESTRADIOL (ELISA) is CHP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kmi Diagnostics, 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.

K010790CORTISOL LIAK990073CALCITONINK973900TESTOTERONE ELISAK973897DHEA-SK973898PROGESTERONE ELISA

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 GmbHK973743ACCESS 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.K965109ELECSYS ESTRADIOL ASSAYBoehringer Mannheim Corp.

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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