The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Quikpac-ii One Step Pregnancy Home Test.
| Device ID | K912316 |
| 510k Number | K912316 |
| Device Name: | QUIKPAC-II ONE STEP PREGNANCY HOME TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | SYNTRON BIORESEARCH, INC. 1080 JOSHUA WAY Vista, CA 92083 |
| Contact | Benedict Zin |
| Correspondent | Benedict Zin SYNTRON BIORESEARCH, INC. 1080 JOSHUA WAY Vista, CA 92083 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-24 |
| Decision Date | 1991-07-24 |