The following data is part of a premarket notification filed by Carter Products with the FDA for Discover(r).
| Device ID | K882232 |
| 510k Number | K882232 |
| Device Name: | DISCOVER(R) |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | CARTER PRODUCTS HALF ACRE RD. Cranbury, NJ 08512 |
| Contact | Stephen Kolakowsky |
| Correspondent | Stephen Kolakowsky CARTER PRODUCTS HALF ACRE RD. Cranbury, NJ 08512 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-27 |
| Decision Date | 1988-10-25 |