FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

124 results for "Wako Chemicals USA, Inc."
1–24 of 124
Search insights Median review: 52d Cleared: 99% Top manufacturer: Wako Chemicals USA, Inc. Lead specialty: Chemistry
Cleared Feb 23, 2011
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL...
K100464 · NSF
Wako Chemicals USA, Inc.
Immunology · 370d
Cleared Jul 18, 2008
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601,...
K080125 · LBS
Wako Chemicals USA, Inc.
Chemistry · 183d
Cleared Jul 17, 2008
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · CFR
Wako Chemicals USA, Inc.
Chemistry · 182d
Cleared Feb 23, 2007
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775 · JFY
Wako Chemicals USA, Inc.
Chemistry · 245d
Cleared Jan 31, 2007
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301
K062368 · OAU
Wako Chemicals USA, Inc.
Immunology · 170d
Cleared Dec 30, 2005
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
K053132 · JFM
Wako Chemicals USA, Inc.
Chemistry · 52d
Cleared Dec 30, 2005
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
K053131 · JFM
Wako Chemicals USA, Inc.
Chemistry · 52d
Not Cleared May 19, 2005
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
DEN050002 · NSF
Wako Chemicals USA, Inc.
Immunology · 42d
Cleared Nov 16, 2004
MULTI-CHEM CALIBRATOR A
K042551 · JIX
Wako Chemicals USA, Inc.
Chemistry · 57d
Cleared Nov 08, 2004
MULTI-LIPID CALIBRATOR
K042550 · JIX
Wako Chemicals USA, Inc.
Chemistry · 49d
Cleared Nov 08, 2004
MULTI CHEM CAL B
K042549 · JIX
Wako Chemicals USA, Inc.
Chemistry · 49d
Cleared May 17, 2004
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
K040918 · JJX
Wako Chemicals USA, Inc.
Chemistry · 39d
Cleared Apr 23, 2004
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
K033860 · JIT
Wako Chemicals USA, Inc.
Chemistry · 133d
Cleared Mar 25, 2004
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN...
K040226 · JIT
Wako Chemicals USA, Inc.
Chemistry · 52d
Cleared Jun 06, 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
K024280 · DCK
Wako Chemicals USA, Inc.
Chemistry · 165d
Cleared Apr 11, 2003
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN...
K030320 · JIS
Wako Chemicals USA, Inc.
Chemistry · 71d
Cleared Feb 24, 2003
WAKO L-TYPE GLUCOSE 2
K024281 · CFR
Wako Chemicals USA, Inc.
Chemistry · 63d
Cleared Feb 11, 2003
WAKO NEFA LINEARITY SET
K030065 · JJX
Wako Chemicals USA, Inc.
Toxicology · 35d
Cleared Sep 09, 2002
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
K020972 · DHR
Wako Chemicals USA, Inc.
Immunology · 167d
Cleared Aug 01, 2001
WAKO IMMUNOASSAY CALIBRATOR SET
K010332 · JIT
Wako Chemicals USA, Inc.
Immunology · 180d
Cleared Jun 25, 2001
WAKO LIPID CALIBRATOR
K010334 · JIT
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
WAKO AUTOKIT C3
K010326 · CZW
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
WAKO AUTOKIT C4
K010325 · DBI
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jan 22, 2001
WAKO CRP-UL, CRP-UL CALIBRATOR SET
K003342 · DCN
Wako Chemicals USA, Inc.
Chemistry · 89d