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FDA 510(k)

ACTIVE TESTOSTERONE EIA (DSL-10-4000)

K-Number: K971823 · 1997-06-16

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1997-06-16
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTIVE TESTOSTERONE EIA (DSL-10-4000) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1997-06-16 under 510(k) number K971823. 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 ACTIVE TESTOSTERONE EIA (DSL-10-4000)?

ACTIVE TESTOSTERONE EIA (DSL-10-4000) is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K971823.

When did ACTIVE TESTOSTERONE EIA (DSL-10-4000) receive FDA 510(k) clearance?

ACTIVE TESTOSTERONE EIA (DSL-10-4000) received FDA 510(k) clearance on 1997-06-16, under 510(k) number K971823.

Who is the listed applicant for ACTIVE TESTOSTERONE EIA (DSL-10-4000)?

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

What is the FDA product code for ACTIVE TESTOSTERONE EIA (DSL-10-4000)?

The FDA product code for ACTIVE TESTOSTERONE EIA (DSL-10-4000) is CDZ.

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Other records listing Diagnostic Systems Laboratories, 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.

K061758ACTIVE RENIN IRMAK020945AXSYM INTACT PTH, MODEL 2G06K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

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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.

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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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