The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Besure Plus/(midstream) One Step Preg Home Test.
| Device ID | K930488 |
| 510k Number | K930488 |
| Device Name: | BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | SYNTRON BIORESEARCH, INC. 1080 JOSHUA WAY Vista, CA 92083 |
| Contact | James P Lee |
| Correspondent | James P Lee 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 | 1993-01-29 |
| Decision Date | 1993-04-06 |