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FDA 510(k)

C-TERMINAL PTH RIA TEST KIT, DSL-1000

K-Number: K813203 · 1981-12-03

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1981-12-03
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

C-TERMINAL PTH RIA TEST KIT, DSL-1000 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 1981-12-03 under 510(k) number K813203. 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 C-TERMINAL PTH RIA TEST KIT, DSL-1000?

C-TERMINAL PTH RIA TEST KIT, DSL-1000 is a medical device that received FDA 510(k) clearance on 1981-12-03. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K813203.

When did C-TERMINAL PTH RIA TEST KIT, DSL-1000 receive FDA 510(k) clearance?

C-TERMINAL PTH RIA TEST KIT, DSL-1000 received FDA 510(k) clearance on 1981-12-03, under 510(k) number K813203.

Who is the listed applicant for C-TERMINAL PTH RIA TEST KIT, DSL-1000?

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 C-TERMINAL PTH RIA TEST KIT, DSL-1000?

The FDA product code for C-TERMINAL PTH RIA TEST KIT, DSL-1000 is CEW.

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Other records listing Diagnostic Systems Laboratories, Inc. as applicant

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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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