Atlas FDA

N LATEX B2-MICROGLOBULIN

FDA 510(k) clearance K002731 · decided 2000-11-20

Clearance details

K-number
K002731
Device name
N LATEX B2-MICROGLOBULIN
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
2000-09-01
Decision date
2000-11-20
Days to decision
80 days
Clearance type
Traditional
Product code
JZG
Device class
2
Regulation number
866.5630
Medical specialty
Immunology
Advisory committee
Immunology
Location
Miami, FL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Dade Behring

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
Beta-2-Microglobulin (K161297)Beckman Coulter Ireland, Inc.2016-06-07
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS (K122066)The Binding Site Group , Ltd.2012-08-30
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR (K110874)Siemens Healthcare Diagnostics, Inc.2012-01-20
HUMAN BETA-2 MICROGLOBULIN KIT (K083289)The Binding Site, Ltd.2009-05-06
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M (K083463)Siemens Healthcare Diagnostics2009-03-13
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 (K072078)Biokit, S.A.2007-12-19
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
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 (K001022)Biocheck, Inc.2000-09-26
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) (K993711)Bayer Corp.1999-12-16

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