The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Infectious Mononucleosis (im) Card & Liquid Test.
| Device ID | K880148 |
| 510k Number | K880148 |
| Device Name: | INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
| Contact | Raymond Gould |
| Correspondent | Raymond Gould AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-13 |
| Decision Date | 1988-02-10 |