FDA 510(k)

ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500

K-Number: K020128 · 2002-03-01

ApplicantDiagnostic Systems Laboratories, Inc.

Decision Date2002-03-01

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 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 2002-03-01 under 510(k) number K020128. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500?

ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 is a medical device that received FDA 510(k) clearance on 2002-03-01. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K020128.

When did ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 receive FDA 510(k) clearance?

ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 received FDA 510(k) clearance on 2002-03-01, under 510(k) number K020128.

Who is the listed applicant for ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500?

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 FREE BETA-HCG ELISA, MODEL DSL-10-8500?

The FDA product code for ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 is JHI.

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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.