Clinical Assays, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K832711VITAMIN B12 FOLATE CA-1515-125October 4, 1983
K832710VITAMIN B12 RADIOASSAY KIT CA-1534October 4, 1983
K832712FOLATE RADIOASSAY KIT CA-1562-125October 4, 1983
K823476GAMMADAB LH RADIO-KIT #CA-1508December 28, 1982
K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTDecember 22, 1982
K821611GAMMADAB [125] FSH RADIOIMMUNAY KITJune 24, 1982
K821092GAMMADAB[125]EGE RADIOIMMUNOASSAY ITJune 22, 1982
K812227GAMMACOAT (125) INSULIN RADIOIMMUNOASSAYSeptember 24, 1981
K810722GASTRIN RADIOIMMUNOASSAY TESTMay 27, 1981
K810967IN-VITRO TBG RADIOIMMUNOASSAY TESTApril 23, 1981
K801667GAMMA COAT(125 I) RUBELLA ANTIBODYOctober 23, 1980
K791497PROSTATIC ACID RADIOIMMUNOASSAY TESTDecember 4, 1979
K791079GAMMADAB (125 1) FOLATE RADIOASSAY KITJuly 17, 1979
K782109RIA KIT, GAMMACOATJanuary 26, 1979
K781938RIA KIT, GAMMADAB ESTRIOLJanuary 10, 1979
K781235IV VITRO GAMMADAB T4 RIA KITAugust 14, 1978
K780934IN VITRO TOBRAMYCIN RIA KITAugust 14, 1978
K780854IN VITRO NEONATAL T4July 27, 1978
K780709IN VITRO GENTAMICIN RADIOIMMUNOASSY TESTMay 12, 1978
K772017IN VITRO THEOPHYLLINE RIA TESTMarch 27, 1978