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510(k) K921249

Device
WAKO AUTOKIT LIPASE-COLOR
Applicant
WAKO CHEMICALS, USA, INC.
510(k) number
K921249
Product code
CHI  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-21
Date received
1992-03-16
Regulation
862.1465
Classification name
Lipase-esterase, Enzymatic, Photometric, Lipase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ED ZIOR
Address
1600 Bellwood Rd. Richmond VA US 23237 23237

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CHI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970905SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENTBeckman Instruments, Inc.1997-06-04
K961179SENTINEL LIPASE LIQUID MODEL 17.401BEqual Diagnostics, Inc.1996-07-19
K952180CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMSBeckman Instruments, Inc.1995-08-17
K952816LIPASE FLEX REAGENT CARTRIDGEDupont Medical Products1995-07-20
K952647IL TEST LIPASEInstrumentation Laboratory CO1995-07-20
K941085LIPASE-PS ASSAY PROCEDURE NO. 805Sigma Diagnostics, Inc.1994-05-17
K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYNuclear Diagnostics, Inc.1994-02-25
K920337MILES LIPASE SERA-PAK METHODHeraeus Kulzer, Inc.1992-03-11
K900827COLORIMETRIC CHLORIDE PRODUCT #4314125American Research Products Co.1990-05-02
K897150LIPASE COLOR [TOYO] SERUM LIPASE TEST KITToyo Jozo Co., Ltd.1990-02-26
K884596ABBOTT A-GENT LIPASE REAGENTAbbott Laboratories1988-12-06
K874027LIPASE UV [TOYO]Advocacy International, Ltd.1988-05-27
K875173KODAK EKTACHEM DT SLIDES (LIPA)Eastman Kodak Company1988-02-24
K874640WAKO(TM) AUTOKIT LIPASEWako Chemicals USA, Inc.1987-12-22
K862312ENZLIPASE, ENZYMATIC LIPASE KITNuclear Diagnostics, Inc.1986-09-26

Legacy Summary#

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FDA Review#

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