The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Mono-plus Positive And Negative Control Set.
| Device ID | K900625 |
| 510k Number | K900625 |
| Device Name: | MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | Kevin T Kearns |
| Correspondent | Kevin T Kearns ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-08 |
| Decision Date | 1990-02-26 |