Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

50 results for "Diazyme Laboratories"
1–24 of 50
Cleared Dec 19, 2025
Diazyme Human Kappa (k) Free Light Chain Assay
K253358 · DFH
Diazyme Laboratories, Inc.
Immunology · 80d
Cleared Aug 01, 2025
Diazyme Colorimetric Lithium Assay
K243462 · NDW
Diazyme Laboratories, Inc.
Chemistry · 266d
Cleared Sep 08, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
K211648 · DFH
Diazyme Laboratories, Inc.
Immunology · 468d
Cleared Aug 04, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
K220001 · DFH
Diazyme Laboratories, Inc.
Immunology · 212d
Cleared Dec 13, 2021
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800...
K212221 · DHA
Diazyme Laboratories, Inc.
Chemistry · 150d
Cleared Aug 06, 2021
Diazyme PLAC® Test for Lp-PLA2 Activity
K203136 · NOE
Diazyme Laboratories, Inc.
Chemistry · 290d
Cleared Oct 04, 2018
Diazyme 1,5-AG Assay
K180209 · NOZ
Diazyme Laboratories, Inc.
Chemistry · 253d
Cleared Jun 26, 2018
Diazyme Human Kappa Free Light Chain Assay
K181438 · DFH
Diazyme Laboratories, Inc.
Immunology · 25d
Cleared Mar 22, 2018
Diazyme Lipoprotein (a) Assay
K180074 · DFC
Diazyme Laboratories, Inc.
Chemistry · 71d
Cleared Jan 11, 2018
Diazyme EZ Vitamin D Assay
K172992 · MRG
Diazyme Laboratories
Chemistry · 106d
Cleared Aug 18, 2017
Diazyme DZ-Lite Total beta-hCG Test System
K163418 · DHA
Diazyme Laboratories
Chemistry · 255d
Cleared Apr 18, 2017
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator...
K162297 · PTF
Diazyme Laboratories
Microbiology · 245d
Cleared Nov 21, 2016
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c...
K160762 · LCP
Diazyme Laboratories
Chemistry · 245d
Cleared Nov 18, 2016
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
K153394 · DFH
Diazyme Laboratories
Immunology · 360d
Cleared Nov 04, 2016
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
K161646 · CGN
Diazyme Laboratories
Chemistry · 142d
Cleared Sep 20, 2016
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme...
K161721 · CDD
Diazyme Laboratories
Chemistry · 90d
Cleared Jan 31, 2016
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme...
K143470 · GIS
Diazyme Laboratories
Hematology · 422d
Cleared Aug 06, 2014
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
K133803 · LCP
Diazyme Laboratories
Chemistry · 233d
Cleared Jun 24, 2014
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN...
K133083 · DBF
Diazyme Laboratories
Immunology · 267d
Cleared Mar 14, 2014
DIAZYME 25-OH VITAMIN D ASSAY
K133410 · MRG
Diazyme Laboratories
Chemistry · 127d
Cleared Jun 26, 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
K131556 · JIT
Diazyme Laboratories
Chemistry · 28d
Cleared Jun 07, 2013
DIAZYME MYOGLOBIN
K123785 · DDR
Diazyme Laboratories
Chemistry · 179d
Cleared Jan 24, 2013
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
K112120 · GHH
Diazyme Laboratories
Hematology · 549d
Cleared Nov 28, 2012
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL...
K122420 · MRG
Diazyme Laboratories
Chemistry · 111d