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FDA 510(k)

CALCITONIN RIA KIT

K-Number: K854240 · 1985-11-22

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1985-11-22
Product CodeJKR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCITONIN RIA KIT 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 1985-11-22 under 510(k) number K854240. The device is classified under product code JKR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALCITONIN RIA KIT?

CALCITONIN RIA KIT is a medical device that received FDA 510(k) clearance on 1985-11-22. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K854240.

When did CALCITONIN RIA KIT receive FDA 510(k) clearance?

CALCITONIN RIA KIT received FDA 510(k) clearance on 1985-11-22, under 510(k) number K854240.

Who is the listed applicant for CALCITONIN RIA KIT?

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 CALCITONIN RIA KIT?

The FDA product code for CALCITONIN RIA KIT is JKR.

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Other records listing Diagnostic Systems Laboratories, Inc. as applicant

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Related Devices (Code: JKR)

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.

K252431Elecsys CalcitoninRoche Diagnostics GmbHK182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics LimitedK132828ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3Roche DiagnosticsK060578CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)Scantibodies Laboratory, Inc.K023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCLDiagnostic Products Corp.K990073CALCITONINKmi Diagnostics, 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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