The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Quikpac Ii, One Step Hcg Combo Kit.
| Device ID | K945951 |
| 510k Number | K945951 |
| Device Name: | QUIKPAC II, ONE STEP HCG COMBO KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | SYNTRON BIORESEARCH, INC. 1080 JOSHUA WAY Vista, CA 92083 |
| Contact | Charles Yu |
| Correspondent | Charles Yu SYNTRON BIORESEARCH, INC. 1080 JOSHUA WAY Vista, CA 92083 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-06 |
| Decision Date | 1995-02-08 |