• FDA 510(k) records for MobileRay Pulse SE Digital Imaging System K191503
1 1

FDA 510(k) K112605, SYSMEX XN-SERIES, by Sysmex America, Inc.

FDA 510(k) K112605, SYSMEX XN-SERIES, by Sysmex America, Inc.

$1,063.53 USD
$1,063.53 USD
Sale Sold out

510(K) Number: K112605
Device Name: SYSMEX XN-SERIES
Manufacturer: Sysmex America, Inc.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 09/07/2011
Decision Date: 10/19/2012
Regulation Medical Specialty: Hematology

Total pages: 7,025
Fully redacted pages: 6,275
Content pages: 750
View full details
FOIA Pro

This drug has a lot more FDA history than one product page can show

FOIA Pro gives you full-text search across 70,000+ FDA FOIA records, from 2020 through today, plus a monthly monitor tracking new requests as they close.
  • Full-text search across every FDA FOIA log since 2020
  • Warning letters, approval records, and correspondence in one place
  • Monthly FDA FOIA Monitor newsletter, included
  • Cancel anytime, monthly or annual billing
Get FOIA Pro
Live search · FOIA database
Searching related FDA records…
ClosedTypeSubjectOutcome