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510(k) K942222

Device
QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
Applicant
ISOLAB, INC.
510(k) number
K942222
Product code
JCM  
Decision
Substantially Equivalent (SESE)
Decision date
1995-01-20
Date received
1994-05-06
Regulation
864.7415
Classification name
Control, Hemoglobin, Abnormal
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JANET D PERKINS
Address
Drawer 4350 Akron OH US 44321 44321

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JCM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K053031EXTENDSURE HBFASC CONTROLCantebury Scientific , Ltd.2005-12-07
K011389HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)Canterbury Health Laboratories2001-06-21
K983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINERoche Diagnostic Systems, Inc.1999-02-10
K933086AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328Helena Laboratories1994-10-31
K931234HEMOCARD CONTROL HB-AA, AE, FAA, FAEIsolab, Inc.1993-05-11
K924173HEMOCARD(TM) CONTROLIsolab, Inc.1992-12-01
K913427SICKLE HEMOGLOBIN (HBA/S) CONTROL SETCreative Laboratory Products, Inc.1991-11-19
K911347LYPHOCHEK(R) HEMOGLOBIN A2 CONTROLBio-Rad1991-06-10
K910431HEMOCARD CONTROLIsolab, Inc.1991-03-11
K820787HELENA ABNORMAL HBA2 QUIK COLUMN CONTROLHelena Laboratories1982-04-08
K820037SICKLE-CHECKDiagnostic Technology, Inc.1982-02-04

Legacy Summary#

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FDA Review#

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