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FDA 510(k) Applications Submitted by Kerrie Oetter
FDA 510(k) Number
Submission Date
Device Name
Applicant
K040025
01/07/2004
A1C-CELLULAR
STRECK LABORATORIES, INC.
K060083
01/11/2006
NRBC-CHEX FOR LH
Streck
K040107
01/20/2004
CYTO-CHEX BCT
STRECK LABORATORIES, INC.
K090137
01/21/2009
STAK-CHEX PLUS RETICS
Streck
K070199
01/22/2007
RETIC-CHEX LINEARITY FOR BC
Streck
K090201
01/27/2009
UA-CELLULAR FOR IQ
Streck
K121214
04/23/2012
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
BECKMAN COULTER, INC.
K101335
05/12/2010
CELL-CHEX
Streck
K121790
06/18/2012
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
BECKMAN COULTER, INC.
K042587
09/22/2004
RETIC-CHEX FOR CELL-DYN
STRECK LABORATORIES, INC.
K063218
10/24/2006
E-CHECK (XE)
Streck
K223403
11/09/2022
LIAISON Anti-HAV; LIAISON XS
DiaSorin Inc.
K053362
12/02/2005
CELL-CHEX AUTO
Streck
K083926
12/31/2008
CD4 COUNT
Streck
K111952
07/11/2011
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
BECKMAN COULTER, INC.
K172783
09/15/2017
Access hs Tnl
Beckman Coulter, Inc.
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