The following data is part of a premarket notification filed by Bio Diagnostic Systems, Inc. with the FDA for Preg-phile B.
| Device ID | K821676 |
| 510k Number | K821676 |
| Device Name: | PREG-PHILE B |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | BIO DIAGNOSTIC SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-08 |
| Decision Date | 1982-07-16 |