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FDA 510(k)

CALCITONIN IMMUNOASSAY KIT

K-Number: K945961 · 1995-11-20

ApplicantNichols Institute Diagnostics
Decision Date1995-11-20
Product CodeJKR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCITONIN IMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1995-11-20 under 510(k) number K945961. 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 IMMUNOASSAY KIT?

CALCITONIN IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1995-11-20. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K945961.

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

CALCITONIN IMMUNOASSAY KIT received FDA 510(k) clearance on 1995-11-20, under 510(k) number K945961.

Who is the listed applicant for CALCITONIN IMMUNOASSAY KIT?

The FDA 510(k) record lists Nichols Institute Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALCITONIN IMMUNOASSAY KIT?

The FDA product code for CALCITONIN IMMUNOASSAY KIT is JKR.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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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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