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FDA 510(k)

SEROZYME CORTISOL TEST KIT

K-Number: K903975 · 1991-01-23

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1991-01-23
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SEROZYME CORTISOL TEST KIT 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 1991-01-23 under 510(k) number K903975. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEROZYME CORTISOL TEST KIT?

SEROZYME CORTISOL TEST KIT is a medical device that received FDA 510(k) clearance on 1991-01-23. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K903975.

When did SEROZYME CORTISOL TEST KIT receive FDA 510(k) clearance?

SEROZYME CORTISOL TEST KIT received FDA 510(k) clearance on 1991-01-23, under 510(k) number K903975.

Who is the listed applicant for SEROZYME CORTISOL TEST KIT?

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 SEROZYME CORTISOL TEST KIT?

The FDA product code for SEROZYME CORTISOL TEST KIT is CGR.

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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: CGR)

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K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.K223038Access CortisolBeckman Coulter, Inc.K202136IDS CortisolImmunodiagnostic Systems , Ltd.K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K062626CORTISOL ELISAIbl-Hamburg GmbH

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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