510(k) K955719

Device: SICKLE-2000
Applicant: MEDICUS TECHNOLOGIES, INC.
510(k) number: K955719
Product code: GIQ
Decision: Substantially Equivalent (SESE)
Decision date: 1996-08-14
Date received: 1995-12-18
Regulation: 864.7415
Classification name: Hemoglobin S
Medical specialty: Hematology
Review panel: Hematology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JOHN F O'DONNELL
Address: 515 S. Franklin St. West Chester PA US 19382 19382

FDA Registration Numbers#

8023024

Source Documents#

Other 510(k) Records For Product Code GIQ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K942276	QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY	Isolab, Inc.	1995-01-20
K874429	HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12	Hf Scientific, Inc.	1988-02-04

Legacy Summary#

summary

FDA Review#

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