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FDA 510(k)

CALCITONIN

K-Number: K990073 · 1999-05-11

ApplicantKmi Diagnostics, Inc.
Decision Date1999-05-11
Product CodeJKR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCITONIN is the device name listed in this FDA 510(k) record. The listed applicant is Kmi Diagnostics, Inc.. It received FDA 510(k) clearance on 1999-05-11 under 510(k) number K990073. 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?

CALCITONIN is a medical device that received FDA 510(k) clearance on 1999-05-11. The listed applicant is Kmi Diagnostics, Inc.. The 510(k) number is K990073.

When did CALCITONIN receive FDA 510(k) clearance?

CALCITONIN received FDA 510(k) clearance on 1999-05-11, under 510(k) number K990073.

Who is the listed applicant for CALCITONIN?

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

What is the FDA product code for CALCITONIN?

The FDA product code for CALCITONIN is JKR.

Related Clinical Trials

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.

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Other records listing Kmi Diagnostics, Inc. 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.

K010790CORTISOL LIAK973900TESTOTERONE ELISAK97390117 B-ESTRADIOL (ELISA)K973897DHEA-SK973898PROGESTERONE ELISA

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.K982491SANGUI BIOTECH, INC. CALCITONIN ELISA KITSangui Biotech, 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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