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FDA 510(k)

DSL ACTIVE PROLACTIN ELISA MODEL 10-4500

K-Number: K960561 · 1996-04-26

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1996-04-26
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 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 1996-04-26 under 510(k) number K960561. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSL ACTIVE PROLACTIN ELISA MODEL 10-4500?

DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 is a medical device that received FDA 510(k) clearance on 1996-04-26. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K960561.

When did DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 receive FDA 510(k) clearance?

DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 received FDA 510(k) clearance on 1996-04-26, under 510(k) number K960561.

Who is the listed applicant for DSL ACTIVE PROLACTIN ELISA MODEL 10-4500?

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 PROLACTIN ELISA MODEL 10-4500?

The FDA product code for DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 is CFT.

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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: CFT)

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.

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobindK970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems Laboratories, Inc.K954680ACCESS PROLACTIN ASSAY (MODIFICATION)Bio-Rad Laboratories, 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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