Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1485945746
Device Listing 1485945746
Listing Summary
#
Listing key
1485945746
Premarket submission
K183440
Device
CRYOcheck FVIII Inhibitor Kit
Applicant
Precision Biologic, Inc.
Product code
GGP
Decision date
2019-03-12
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
76082
8043599
3005917516
Precision BioLogic Inc.
1
N
2027-01-01
140 Eileen Stubbs Avenue Dartmouth Nova Scotia CA B3B 0A9