Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)

K-Number: K914429 · 1992-01-15

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1992-01-15
Product CodeJKR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) 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 1992-01-15 under 510(k) number K914429. 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 DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)?

DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) is a medical device that received FDA 510(k) clearance on 1992-01-15. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K914429.

When did DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) receive FDA 510(k) clearance?

DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) received FDA 510(k) clearance on 1992-01-15, under 510(k) number K914429.

Who is the listed applicant for DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)?

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 DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)?

The FDA product code for DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) 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 Diagnostic Systems Laboratories, 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.

K061758ACTIVE RENIN IRMAK020945AXSYM INTACT PTH, MODEL 2G06K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

View all 94 devices →

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.

↑