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FDA 510(k)

SANGUI BIOTECH, INC. CALCITONIN ELISA KIT

K-Number: K982491 · 1998-09-03

ApplicantSangui Biotech, Inc.
Decision Date1998-09-03
Product CodeJKR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SANGUI BIOTECH, INC. CALCITONIN ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sangui Biotech, Inc.. It received FDA 510(k) clearance on 1998-09-03 under 510(k) number K982491. 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 SANGUI BIOTECH, INC. CALCITONIN ELISA KIT?

SANGUI BIOTECH, INC. CALCITONIN ELISA KIT is a medical device that received FDA 510(k) clearance on 1998-09-03. The listed applicant is Sangui Biotech, Inc.. The 510(k) number is K982491.

When did SANGUI BIOTECH, INC. CALCITONIN ELISA KIT receive FDA 510(k) clearance?

SANGUI BIOTECH, INC. CALCITONIN ELISA KIT received FDA 510(k) clearance on 1998-09-03, under 510(k) number K982491.

Who is the listed applicant for SANGUI BIOTECH, INC. CALCITONIN ELISA KIT?

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

What is the FDA product code for SANGUI BIOTECH, INC. CALCITONIN ELISA KIT?

The FDA product code for SANGUI BIOTECH, INC. CALCITONIN ELISA KIT 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sangui Biotech, 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.

K001943CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAYK992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITK982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITK974306SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) 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.K990073CALCITONINKmi Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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