The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Besure One-=step Home Ovulation Predictor Kit.
| Device ID | K951538 |
| 510k Number | K951538 |
| Device Name: | BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | SYNTRON BIORESEARCH, INC. 2774 LOKER AVE. WEST Carlsbad, CA 92008 |
| Contact | Charles Yu |
| Correspondent | Charles Yu SYNTRON BIORESEARCH, INC. 2774 LOKER AVE. WEST Carlsbad, CA 92008 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-03 |
| Decision Date | 1995-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311917198870 | K951538 | 000 |