The following data is part of a premarket notification filed by Bio Diagnostic Systems, Inc. with the FDA for Mono-phile.
| Device ID | K881247 |
| 510k Number | K881247 |
| Device Name: | MONO-PHILE |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | BIO DIAGNOSTIC SYSTEMS, INC. 1 WALL ST. Princeton, NJ 08540 |
| Contact | Bernard Fishbein |
| Correspondent | Bernard Fishbein BIO DIAGNOSTIC SYSTEMS, INC. 1 WALL ST. Princeton, NJ 08540 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-23 |
| Decision Date | 1988-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838065385 | K881247 | 000 |
| 00848838065279 | K881247 | 000 |
| 00848838065262 | K881247 | 000 |