Antibodies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K890774GIARDEIA(TM)April 4, 1989
K843590DETECT-A-STREPOctober 30, 1984
K822892CORTISOL RIA KITNovember 1, 1982
K812749ULTRA-DIGOctober 19, 1981
K812314CRITHIDNA ANTI-DNA TEST KITSeptember 1, 1981
K802877AMIKACIN RIA KITDecember 19, 1980
K800743TOBRAMYCIN RIA KITApril 16, 1980
K791217TSH RIA KITSeptember 4, 1979
K781654NEPHELRATE ANTIPERUMS LGMNovember 8, 1978
K781656NEPHELRATE ANTISERUMS, IGGNovember 8, 1978
K781655NEPHELRATE ANTISERUMS 1GANovember 8, 1978
K781653NEPHELRATE ANTISERUMS C3CNovember 8, 1978
K780516GENTAMICIN RIA KITApril 28, 1978
K772122T3 RIA KITNovember 17, 1977
K771877DIGOXIN RIA KITOctober 21, 1977
K771585T3 UPTAKE DIAG. KITSeptember 13, 1977