FDA 510(k)

ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100

K-Number: K002128 · 2000-12-05

ApplicantDiagnostic Systems Laboratories, Inc.

Decision Date2000-12-05

Product CodeNDR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 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 2000-12-05 under 510(k) number K002128. The device is classified under product code NDR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100?

ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 is a medical device that received FDA 510(k) clearance on 2000-12-05. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K002128.

When did ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 receive FDA 510(k) clearance?

ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 received FDA 510(k) clearance on 2000-12-05, under 510(k) number K002128.

Who is the listed applicant for ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100?

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 INHIBIN-A ELISA, MODEL DSL-10-28100?

The FDA product code for ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 is NDR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.