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)

COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.

K-Number: K854938 · 1986-03-12

ApplicantDiatech, Inc.
Decision Date1986-03-12
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1986-03-12 under 510(k) number K854938. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.?

COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. is a medical device that received FDA 510(k) clearance on 1986-03-12. The listed applicant is Diatech, Inc.. The 510(k) number is K854938.

When did COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. receive FDA 510(k) clearance?

COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. received FDA 510(k) clearance on 1986-03-12, under 510(k) number K854938.

Who is the listed applicant for COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.?

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

What is the FDA product code for COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.?

The FDA product code for COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. is JPA.

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 Diatech, 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.

K881685FIBRINOGENTEST-OK854090DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENTK854089DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENTK842286DIA T1, T2 & T3K841365DIA REPTINK841462HEPARIN COAGULATION CONTROL PLASMA 1-

View all 17 devices →

Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

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.

↑