The following data is part of a premarket notification filed by Vanguard Biomedical Corp. with the FDA for Proclinic One Step Pregnancy Test.
| Device ID | K914253 |
| 510k Number | K914253 |
| Device Name: | PROCLINIC ONE STEP PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | VANGUARD BIOMEDICAL CORP. 7822 CONVOY COURT San Diego, CA 92111 |
| Contact | John Chiu |
| Correspondent | John Chiu VANGUARD BIOMEDICAL CORP. 7822 CONVOY COURT San Diego, CA 92111 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-23 |
| Decision Date | 1991-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066000274 | K914253 | 000 |
| 00722066000229 | K914253 | 000 |