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)

KINETI COUNT 48 IMMUNOASSAY SYSTEM

K-Number: K830365 · 1983-03-10

ApplicantMedical & Scientific Designs, Inc.
Decision Date1983-03-10
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KINETI COUNT 48 IMMUNOASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical & Scientific Designs, Inc.. It received FDA 510(k) clearance on 1983-03-10 under 510(k) number K830365. The device is classified under product code JJJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KINETI COUNT 48 IMMUNOASSAY SYSTEM?

KINETI COUNT 48 IMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1983-03-10. The listed applicant is Medical & Scientific Designs, Inc.. The 510(k) number is K830365.

When did KINETI COUNT 48 IMMUNOASSAY SYSTEM receive FDA 510(k) clearance?

KINETI COUNT 48 IMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1983-03-10, under 510(k) number K830365.

Who is the listed applicant for KINETI COUNT 48 IMMUNOASSAY SYSTEM?

The FDA 510(k) record lists Medical & Scientific Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KINETI COUNT 48 IMMUNOASSAY SYSTEM?

The FDA product code for KINETI COUNT 48 IMMUNOASSAY SYSTEM is JJJ.

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 Medical & Scientific Designs, 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.

K862960PHASE II FERRITIN RADIOIMMUNOASSAY KITK853224PHASE II B-12/FOLATE KITK840901PHASE II FREE T4 KITK840328PHASE II HCG KITK834219PHASE II CORTISOL KITK833789PHASE II THEOPHYLLINE RADIOIMMUNOASSAY

View all 14 devices →

Related Devices (Code: JJJ)

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.

K962762SEQUENTIAL SAMPLE MULTI-PHOTON DETECTORBiotraces, Inc.K946387CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTERCapintec, Inc.K920559ABBOTT VERTEX ANALYZERAbbott LaboratoriesK900087GENESYS 6000 GAMMA COUNTERLaboratory Technologies, Inc.K896202MATRIX(TM)-96Canberra Industries, Inc.K894902SOURCEREROakfield Instruments, Ltd.

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.

↑