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FDA 510(k)

DSL I-PTH (DSL #8000)

K-Number: K896294 · 1989-11-21

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1989-11-21
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL I-PTH (DSL #8000) 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 1989-11-21 under 510(k) number K896294. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSL I-PTH (DSL #8000)?

DSL I-PTH (DSL #8000) is a medical device that received FDA 510(k) clearance on 1989-11-21. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K896294.

When did DSL I-PTH (DSL #8000) receive FDA 510(k) clearance?

DSL I-PTH (DSL #8000) received FDA 510(k) clearance on 1989-11-21, under 510(k) number K896294.

Who is the listed applicant for DSL I-PTH (DSL #8000)?

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 I-PTH (DSL #8000)?

The FDA product code for DSL I-PTH (DSL #8000) is CEW.

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: CEW)

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.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

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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