Gibson Laboratories LLC

FDA Regulatory Profile

Gibson Laboratories LLC appears in FDA public data with 1 recall, 4 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0606-2018, Class II) was initiated on January 20, 2017. Its most recent 510(k) clearance was granted on February 29, 1996.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0606-2018Class IIBlastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for idenJanuary 20, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K955826GIBSON ID-M. CAT.February 29, 1996
K953247GIBSON ID A.E. TESTNovember 20, 1995
K905120SAF FIXATIVEDecember 17, 1990
K904773P AND T MEDIUMDecember 4, 1990