The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Resolve-csf.
Device ID | K843122 |
510k Number | K843122 |
Device Name: | RESOLVE-CSF |
Classification | Total Spinal-fluid, Antigen, Antiserum, Control |
Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
Contact | Loren F Hazelwood |
Correspondent | Loren F Hazelwood ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
Product Code | DFI |
CFR Regulation Number | 866.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-08 |
Decision Date | 1984-11-30 |