Monoclonal Antibodies, Inc. - FDA 510(k) Cleared Devices
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Monoclonal Antibodies, Inc. Chemistry ✕
13 devices
Cleared
Jul 27, 1987
OVUQUICK SELF-TEST (OVUQUICK
Chemistry
83d
Cleared
Nov 05, 1986
HCG CONTROL KIT
Chemistry
42d
Cleared
Jul 02, 1986
RAMP PROGESTURINE PDG ASSAY--48 TEST KIT
Chemistry
113d
Cleared
Dec 30, 1985
RAMP URINE HCG ASSAY
Chemistry
42d
Cleared
Apr 02, 1985
MODEL SERUM HCG ASSAY
Chemistry
39d
Cleared
Mar 05, 1985
OVU STICK SELF-TEST -MODIFICATION
Chemistry
34d
Cleared
Dec 11, 1984
OVUSTICK SELF-TEST
Chemistry
113d
Cleared
Apr 19, 1984
PLUS URINE HCG ASSAY
Chemistry
58d
Cleared
Apr 13, 1984
OVU STICK URINE HLH KIT
Chemistry
73d
Cleared
Jan 09, 1984
PREGNASTICK URINE HCG KIT
Chemistry
96d
Cleared
Sep 12, 1983
SERUM HCG ASSAY
Chemistry
41d
Cleared
Jun 02, 1983
B-CLONE HCG ASSAY
Chemistry
55d
Cleared
Sep 28, 1982
MODEL UCG ASSAY
Chemistry
36d