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FDA 510(k)

ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)

K-Number: K912318 · 1991-07-25

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1991-07-25
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) 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 1991-07-25 under 510(k) number K912318. 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 ENZYME IMMUNO (MAG SOLID-PHASE)?

ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) is a medical device that received FDA 510(k) clearance on 1991-07-25. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K912318.

When did ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) receive FDA 510(k) clearance?

ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) received FDA 510(k) clearance on 1991-07-25, under 510(k) number K912318.

Who is the listed applicant for ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)?

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 ENZYME IMMUNO (MAG SOLID-PHASE)?

The FDA product code for ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) is CHP.

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Other records listing Serono-Baker 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.

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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