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FDA 510(k)

FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900

K-Number: K001086 · 2000-05-18

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date2000-05-18
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 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 2000-05-18 under 510(k) number K001086. 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 FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900?

FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 is a medical device that received FDA 510(k) clearance on 2000-05-18. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K001086.

When did FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 receive FDA 510(k) clearance?

FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 received FDA 510(k) clearance on 2000-05-18, under 510(k) number K001086.

Who is the listed applicant for FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900?

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 FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900?

The FDA product code for FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 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.

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Related Devices (Code: CDZ)

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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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