DDS · Class I · 21 CFR 866.5060

FDA Product Code DDS: Prealbumin, Fitc, Antigen, Antiserum, Control

Leading manufacturers include Beckman Instruments, Inc., Incstar Corp. and Hemagen Diagnostics, Inc..

4
Total
4
Cleared
84d
Avg days
1986
Since

FDA 510(k) Cleared Prealbumin, Fitc, Antigen, Antiserum, Control Devices (Product Code DDS)

4 devices
1–4 of 4
Cleared Aug 28, 1997
RAICHEM PREALBUMIN SPIA
K972812
Hemagen Diagnostics, Inc.
Immunology · 31d
Cleared May 09, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
K964781
Beckman Instruments, Inc.
Immunology · 163d
Cleared Jan 11, 1994
SPQ PAL CONTROL LEVEL II
K934966
Incstar Corp.
Immunology · 88d
Cleared Jan 24, 1986
ICS PAB PREALBUMIN REAGENT TEST KIT
K854811
Beckman Instruments, Inc.
Immunology · 52d

About Product Code DDS - Regulatory Context