Device product

Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in the analysis of dried blood spots and other biological matrices in research applications for drug metabolism pharmacokinetics/ absorption, distribution. metabolism and excretion (DMPK/ ADME) studies.

Z-1737-2017

June 17, 2015

Class II

Product summary

Firm: Agilent Technologies, Inc.
Event: Event 76698
Status: Terminated
Classification: Class II
Quantity: 364 in total
Official record key: device-enforcement:Z-1737-2017

Official wording

Reason: The product was marketed without 510(k) clearance.

Code information: All

Distribution pattern: US and Australia, Thailand, Great Britain, Germany, Japan, Netherlands, France, Taiwan, Canada, South Africa, China, Slovenia, Spain, Italy, Norway, India, Russia, Finland, Czech Republic, Singapore, Denmark, Korea, Ireland, United Arab Emirates, .Belgium, Switzerland and Sweden.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The product was marketed without 510(k) clearance.