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FDA 510(k)

CALCITONIN 125

K-Number: K781909 · 1979-01-10

ApplicantCambridge Nuclear Radiopharmaceutical
Decision Date1979-01-10
Product CodeJKR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCITONIN 125 is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Nuclear Radiopharmaceutical. It received FDA 510(k) clearance on 1979-01-10 under 510(k) number K781909. 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 125?

CALCITONIN 125 is a medical device that received FDA 510(k) clearance on 1979-01-10. The listed applicant is Cambridge Nuclear Radiopharmaceutical. The 510(k) number is K781909.

When did CALCITONIN 125 receive FDA 510(k) clearance?

CALCITONIN 125 received FDA 510(k) clearance on 1979-01-10, under 510(k) number K781909.

Who is the listed applicant for CALCITONIN 125?

The FDA 510(k) record lists Cambridge Nuclear Radiopharmaceutical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALCITONIN 125?

The FDA product code for CALCITONIN 125 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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