LIM · Class II · 21 CFR 864.7455

FDA Product Code LIM: Test, Screening, For D Positive Fetal Rbc's

Leading manufacturers include Gamma Biologicals, Inc. and Biopool Intl., Inc..

2
Total
2
Cleared
68d
Avg days
1982
Since

FDA 510(k) Cleared Test, Screening, For D Positive Fetal Rbc's Devices (Product Code LIM)

2 devices
1–2 of 2
Cleared Apr 08, 1998
FETAL D TECTION KIT
K980314
Biopool Intl., Inc.
Hematology · 71d
Cleared May 12, 1982
GAMMA FETAL BLEED SCREENING TEST
K820647
Gamma Biologicals, Inc.
Hematology · 64d

About Product Code LIM - Regulatory Context