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)

EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628

K-Number: K875062 · 1988-02-11

ApplicantEm Diagnostic Systems, Inc.
Decision Date1988-02-11
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1988-02-11 under 510(k) number K875062. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628?

EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 is a medical device that received FDA 510(k) clearance on 1988-02-11. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K875062.

When did EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 receive FDA 510(k) clearance?

EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 received FDA 510(k) clearance on 1988-02-11, under 510(k) number K875062.

Who is the listed applicant for EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628?

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

What is the FDA product code for EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628?

The FDA product code for EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 is GJS.

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 Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

View all 288 devices →

Related Devices (Code: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

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.

↑