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FDA 510(k)

ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE

K-Number: K861361 · 1986-06-27

ApplicantSerono Diagnostics, Inc.
Decision Date1986-06-27
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-06-27 under 510(k) number K861361. 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 MAIA RIA KIT MAGNETIC SEPARATION PHASE?

ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE is a medical device that received FDA 510(k) clearance on 1986-06-27. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K861361.

When did ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE receive FDA 510(k) clearance?

ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE received FDA 510(k) clearance on 1986-06-27, under 510(k) number K861361.

Who is the listed applicant for ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE?

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

What is the FDA product code for ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE?

The FDA product code for ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE is CHP.

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Other records listing Serono 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.

K953598SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERSK942051SR1 DHEA-S ENZYME IMMUNOASSAYK883085T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHASK882340LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHAK880388T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASEK874866T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE

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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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