The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for I.m.n. Latex.
Device ID | K874678 |
510k Number | K874678 |
Device Name: | I.M.N. LATEX |
Classification | System, Test, Infectious Mononucleosis |
Applicant | BIOKIT USA, INC. CORCEGA 603-605 08025 Barcelona, Spain , |
Contact | Guixer |
Correspondent | Guixer BIOKIT USA, INC. CORCEGA 603-605 08025 Barcelona, Spain , |
Product Code | KTN |
CFR Regulation Number | 866.5640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-13 |
Decision Date | 1987-12-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613647001325 | K874678 | 000 |
00613647001318 | K874678 | 000 |
00613647001301 | K874678 | 000 |
00840733101298 | K874678 | 000 |