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)

MINISTAT-S CHEMISTRY ANALYZER

K-Number: K771591 · 1977-09-20

ApplicantBiokinetix Corp.
Decision Date1977-09-20
Product CodeJJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MINISTAT-S CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Biokinetix Corp.. It received FDA 510(k) clearance on 1977-09-20 under 510(k) number K771591. The device is classified under product code JJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINISTAT-S CHEMISTRY ANALYZER?

MINISTAT-S CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1977-09-20. The listed applicant is Biokinetix Corp.. The 510(k) number is K771591.

When did MINISTAT-S CHEMISTRY ANALYZER receive FDA 510(k) clearance?

MINISTAT-S CHEMISTRY ANALYZER received FDA 510(k) clearance on 1977-09-20, under 510(k) number K771591.

Who is the listed applicant for MINISTAT-S CHEMISTRY ANALYZER?

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

What is the FDA product code for MINISTAT-S CHEMISTRY ANALYZER?

The FDA product code for MINISTAT-S CHEMISTRY ANALYZER is JJI.

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

Related Devices (Code: JJI)

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.

K972024CODA AUTOMATED EIA ANALYZERBio-RadK944731ABBOTT IMX 2 ANALYZERAbbott LaboratoriesK931970ABBOTT IMX2 ANALYERAbbott LaboratoriesK930898RADIAS AUTOMATED IMMUNOASSAY SYSTEMBio-RadK790073ANALYZER, IMPACT 100Gilford Instrument Laboratories, Inc.K780972QUICKRATE REACTION RATE ANALYZEROlympus Corp.

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.

↑