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FDA 510(k)

TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY

K-Number: K924257 · 1992-11-30

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1992-11-30
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY 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 1992-11-30 under 510(k) number K924257. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY?

TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1992-11-30. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K924257.

When did TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1992-11-30, under 510(k) number K924257.

Who is the listed applicant for TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY?

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 TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY?

The FDA product code for TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY is CDZ.

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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.

K915164SRI TESTOSTERONE ENZYME IMMUNOASSAYK914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)K915602SRI DIGOXIN ENZYME IMMUNOASSAYK912937SR1 FREE T4 ENZYME IMMUNOASSAYK914462SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)K911912SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)

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Related Devices (Code: CDZ)

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.

K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems LimitedK240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems LimitedK233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche DiagnosticsK201908LIAISON Testosterone xtDiaSorin, 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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