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FDA 510(k)

ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY

K-Number: K896145 · 1989-12-27

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1989-12-27
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Serono-Baker Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-12-27 under 510(k) number K896145. 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 SEROZYME IMMUNOENZYMETRIC ASSAY?

ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K896145.

When did ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY receive FDA 510(k) clearance?

ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance on 1989-12-27, under 510(k) number K896145.

Who is the listed applicant for ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY?

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

What is the FDA product code for ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY?

The FDA product code for ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY is CHP.

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Other records listing Serono-Baker Diagnostics, Inc. as applicant

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K924257TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYK915164SRI TESTOSTERONE ENZYME IMMUNOASSAYK914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)K915602SRI DIGOXIN ENZYME IMMUNOASSAYK912937SR1 FREE T4 ENZYME IMMUNOASSAYK914462SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)

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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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