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FDA 510(k)

DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

K-Number: K990138 · 1999-06-21

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1999-06-21
Product CodeLOJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 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 1999-06-21 under 510(k) number K990138. The device is classified under product code LOJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSL ACTIVE AFP ELISA, MODEL DSL-10-8400?

DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 is a medical device that received FDA 510(k) clearance on 1999-06-21. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K990138.

When did DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 receive FDA 510(k) clearance?

DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 received FDA 510(k) clearance on 1999-06-21, under 510(k) number K990138.

Who is the listed applicant for DSL ACTIVE AFP ELISA, MODEL DSL-10-8400?

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 DSL ACTIVE AFP ELISA, MODEL DSL-10-8400?

The FDA product code for DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 is LOJ.

Related Clinical Trials

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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-10-4900K981871C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100

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Related Devices (Code: LOJ)

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.

K220176Elecsys AFPRoche DiagnosticsK213626VITROS AFPOrtho Clinical DiagnosticsK090236DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454Siemens Healthcare DiagnosticsK081709OLYMPUS AFP - ALPHA-FETOPROTEINOlympus Life Science Research Europa GmbH (Europa)K080017VIDAS AFP ASSAYbioMerieux, Inc.K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600Dade Behring, 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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