GKB · Class I · 21 CFR 864.5800

FDA Product Code GKB: Device, Automated Sedimentation Rate

Leading manufacturers include Gespac, Inc..

2
Total
2
Cleared
26d
Avg days
1989
Since

FDA 510(k) Cleared Device, Automated Sedimentation Rate Devices (Product Code GKB)

2 devices
1–2 of 2
Cleared May 24, 1989
SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED
K892522
Gespac, Inc.
Hematology · 43d
Cleared Feb 10, 1989
SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE
K890503
Gespac, Inc.
Hematology · 9d

About Product Code GKB - Regulatory Context