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FDA 510(k)

CALCITONIN RIA TEST KIT, DLS 1200

K-Number: K821675 · 1982-06-22

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1982-06-22
Product CodeJKR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCITONIN RIA TEST KIT, DLS 1200 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 1982-06-22 under 510(k) number K821675. 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 TEST KIT, DLS 1200?

CALCITONIN RIA TEST KIT, DLS 1200 is a medical device that received FDA 510(k) clearance on 1982-06-22. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K821675.

When did CALCITONIN RIA TEST KIT, DLS 1200 receive FDA 510(k) clearance?

CALCITONIN RIA TEST KIT, DLS 1200 received FDA 510(k) clearance on 1982-06-22, under 510(k) number K821675.

Who is the listed applicant for CALCITONIN RIA TEST KIT, DLS 1200?

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 TEST KIT, DLS 1200?

The FDA product code for CALCITONIN RIA TEST KIT, DLS 1200 is JKR.

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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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