Gelman Sciences, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
32
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K946190DRUG DISPENSING SPIKEMarch 17, 1995
K943127PHARMASSURE LARGE VOLUME TRANSFER FILTERSSeptember 29, 1994
K941589SYRINGE FILTER DEVICESSeptember 6, 1994
K941020DRUG RECONSTITUTION FILTER DEVICEAugust 10, 1994
K942275VIAL VENT FILTERJuly 26, 1994
K941032UNKNOWNMay 27, 1994
K910821TRANSDUCER PROTECTORAugust 12, 1991
K892387MODIFIED GELMAN ARTERIAL FILTERJune 22, 1989
K884176CHROMATOGRAPHY KITApril 4, 1989
K884177DRUG STANDARD SETFebruary 17, 1989
K884178DRUG CONTROL SETFebruary 17, 1989
K862068GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)August 8, 1986
K850260GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETERFebruary 27, 1985
K850202GELMAN TRIPHOR CONTROLFebruary 6, 1985
K842052GIARDIA GUARDSeptember 11, 1984
K842485OPTICLEARAugust 10, 1984
K842560OPTIPHOR-10August 10, 1984
K823550CK-ISOZYME U.V. REAGENT SETJanuary 7, 1983
K822121ACRO PACKAugust 5, 1982
K821303HI-PHORE HIGH RESOLUTION ELECTROPHORESMay 12, 1982