Atlas FDA

CONTROL PLASMA N

FDA 510(k) clearance K023309 · decided 2002-11-01

Clearance details

K-number
K023309
Device name
CONTROL PLASMA N
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
2002-10-03
Decision date
2002-11-01
Days to decision
29 days
Clearance type
Traditional
Product code
GIZ
Device class
2
Regulation number
864.5425
Medical specialty
Hematology
Advisory committee
Hematology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW (K060968)Wortham Laboratories, Inc.2007-05-15
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS (K042941)Dade Behring, Inc.2004-12-02
REFERENCE CHECK, CATALOG NUMBER-RCN-10 (K013708)Precision Biologic2001-12-10
ACCUCLOT CONTROL I, MODEL A4089 (K003328)Sigma Diagnostics, Inc.2001-03-01
CONTROL PLASMA N (K001256)Dade Behring, Inc.2000-05-24
COAGULATION CONTROL LEVEL 1 (NORMAL) (K984129)Pacific Hemostasis1998-12-01
ACCUCOLOR HIGH CALIBRATOR (A3089) (K973274)Sigma Diagnostics, Inc.1997-10-31
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS (K961814)Cardiovascular Diagnostics, Inc.1996-08-13
SPECIALTY ASSAYED CONTROL-1 (K941737)Helena Laboratories1994-10-07
DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (K935254)American Diagnostica, Inc.1994-09-19
CONTROL PLASMA N (K924403)Behring Diagnostics, Inc.1994-02-22
COAGULATION REFERENCE PLASMA, NORMAL (K932145)American Diagnostic Corp.1993-10-18

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003)Dade Behring, Inc.2002-07-24
COBAS INTEGRA CYCLOSPORINE (P920031/S002)Dade Behring, Inc.2002-02-26
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001)Dade Behring, Inc.2000-08-11
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031)Dade Behring, Inc.1996-10-02