The following data is part of a premarket notification filed by Simex Medical, Inc. with the FDA for Modification Of: Davidstrip Hcg.
| Device ID | K991067 |
| 510k Number | K991067 |
| Device Name: | MODIFICATION OF: DAVIDSTRIP HCG |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | SIMEX MEDICAL, INC. 560 INDUSTRY DR. Tukwila, WA 98188 |
| Contact | Michelle J Hall |
| Correspondent | Michelle J Hall SIMEX MEDICAL, INC. 560 INDUSTRY DR. Tukwila, WA 98188 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-30 |
| Decision Date | 1999-04-27 |