The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Syntron Bioresearch U-test Pregnancy Test.
| Device ID | K874248 |
| 510k Number | K874248 |
| Device Name: | SYNTRON BIORESEARCH U-TEST PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | SYNTRON BIORESEARCH, INC. 4202 SORRENTO VALLEY BLVD. SUITE G San Diego, CA 92121 |
| Contact | Shung-ho Chang |
| Correspondent | Shung-ho Chang SYNTRON BIORESEARCH, INC. 4202 SORRENTO VALLEY BLVD. SUITE G San Diego, CA 92121 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-16 |
| Decision Date | 1987-11-04 |