Medical Device Manufacturer · US , Los Angeles , CA

The Binding Site Group , Ltd. - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 2010
43
Total
43
Cleared
0
Denied
41 devices
26-41 of 41
Cleared Apr 16, 2014
HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
K140664 · DEB
Immunology · 29d
Cleared Jul 03, 2013
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
K123256 · DEM
Immunology · 258d
Cleared Jun 19, 2013
HUMAN ALBUMIN CSF KIT
K121045 · DCF
Immunology · 439d
Cleared Jun 03, 2013
HUMAN CAERULOPLASMIN KIT
K122965 · DDB
Immunology · 252d
Cleared May 30, 2013
HUMAN IGA CSF KIT FOR USE ON SPAPLUS
K120901 · CFN
Immunology · 430d
Cleared May 17, 2013
HUMAN IGG CSF KIT
K120749 · CFN
Immunology · 431d
Cleared May 17, 2013
HUMAN IGM CSF KIT
K120750 · CFN
Immunology · 431d
Cleared Apr 15, 2013
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
K122304 · DBA
Immunology · 257d
Cleared Apr 01, 2013
HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
K120056 · DFH
Immunology · 448d
Cleared Mar 27, 2013
HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
K113823 · CFN
Immunology · 456d
Cleared Feb 13, 2013
TRANSFERRIN KIT FOR USE ON THE SPAPLUS
K120236 · DDG
Immunology · 384d
Cleared Aug 30, 2012
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS
K122066 · JZG
Immunology · 45d
Cleared Jul 11, 2012
HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR...
K113349 · DAE
Immunology · 240d
Cleared Aug 16, 2010
HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
K100588 · CFN
Immunology · 167d
Cleared Aug 13, 2010
SPAPLUS
K100179 · CZW
Immunology · 204d
Cleared Mar 01, 2010
HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
K082823 · CFN
Immunology · 522d
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