Atlas FDA

HEMOCHRON(R) HEPARIN RESPONSE TEST

FDA 510(k) clearance K904003 · decided 1990-11-29

Clearance details

K-number
K904003
Device name
HEMOCHRON(R) HEPARIN RESPONSE TEST
Applicant
Intensive Technology, Inc.
Decision
Substantially Equivalent
Date received
1990-08-29
Decision date
1990-11-29
Days to decision
92 days
Clearance type
Traditional
Product code
KFF
Device class
2
Regulation number
864.7525
Medical specialty
Hematology
Advisory committee
Hematology
Location
Edison, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Cel recall (Z-2110-2010)International Technidyne Corp.2010-07-28

PMA approvals by this applicant

RecordFirmDate
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S004)Intensive Technology, Inc.1998-12-30
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S005)Intensive Technology, Inc.1998-02-23
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S003)Intensive Technology, Inc.1998-01-29
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S002)Intensive Technology, Inc.1996-09-17
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S001)Intensive Technology, Inc.1995-01-05
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019)Intensive Technology, Inc.1993-05-18