Atlas FDA

AURAFLEX B2-MICROGLOBULIN

FDA 510(k) clearance K944846 · decided 1995-06-20

Clearance details

K-number
K944846
Device name
AURAFLEX B2-MICROGLOBULIN
Applicant
Organon Teknika Corp.
Decision
Substantially Equivalent
Date received
1994-09-30
Decision date
1995-06-20
Days to decision
263 days
Clearance type
Traditional
Product code
JZG
Device class
2
Regulation number
866.5630
Medical specialty
Immunology
Advisory committee
Immunology
Location
Durham, NC, US
Third-party review
No
Expedited review
No

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DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH (K063272)Dade Behring, Inc.2007-01-26
QUANTIA BETA-2 MICROGLOBULIN (K050613)Biokit, S.A.2005-08-16
DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (K032692)Dako A/S2004-01-22
MININEPH HUMAN B2-MICROGLOBULIN KIT (K014270)The Binding Site, Ltd.2002-08-15
N LATEX B2-MICROGLOBULIN (K002731)Dade Behring, Inc.2000-11-20
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018/S001)Organon Teknika Corp.1990-03-21
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST (P840070/S001)Organon Teknika Corp.1990-03-21
9EPANOSTIKA(TM) ANTI-HAV IGM (P830017/S001)Organon Teknika Corp.1990-03-21
AUTOBAC MIC TEST SYSTEM (N50524/S033)Organon Teknika Corp.1990-01-22
AUTOBAC MIC TEST SYSTEM (N50524/S035)Organon Teknika Corp.1989-12-07
AUTOBAC MIC TEST SYSTEM (N50524/S032)Organon Teknika Corp.1989-06-13
HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018)Organon Teknika Corp.1989-02-06
AUTOBAC MIC TEST SYSTEM (N50524/S031)Organon Teknika Corp.1988-12-28