Pro-Lab, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K934383PROLEX (STREPTOCCAL GROUPING LATEX KIT)January 27, 1995
K914419AMNIOTEST(TM)September 1, 1993
K921421LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYJuly 28, 1992
K903714E. COLI 0157 LATEX TESTJanuary 24, 1991
K894221ROSCO PYRRSeptember 28, 1989
K883996X-ACT LDC/INDOctober 12, 1988
K883995X-ACT UREA/TDAOctober 12, 1988
K871121PROTECT T.M.April 14, 1987
K870117NEISSERIA/BRANHAMELLA DIFFERENTIAL TESTMarch 20, 1987
K861142MASTER KIT BJuly 10, 1986
K861888HIPPURATE HYDROLYSIS TESTJune 3, 1986
K861889D'ALA RAPID TESTJune 3, 1986
K850246MASTER KIT AApril 9, 1985
K850302SUPLEX & SUPLEX DILUENTMarch 22, 1985
K850299C.N.V.T.March 20, 1985
K850308C.L.A.T.March 20, 1985
K850307CAMPYLOBACTER SUPPLEMENT-BLASER/WANGMarch 20, 1985
K850301YEAST DIALYSATEMarch 20, 1985
K850300MUCOLYSEMarch 20, 1985
K850306CAMPYLOBACTER SUPPLEMENT -SKIRROWMarch 20, 1985