The following data is part of a premarket notification filed by Biochemical Diagnostic, Inc. with the FDA for Pregnancy-skreen.
| Device ID | K050328 |
| 510k Number | K050328 |
| Device Name: | PREGNANCY-SKREEN |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BIOCHEMICAL DIAGNOSTIC, INC. 180 HEARTLAND BLVD. Brentwood, NY 11717 |
| Contact | Allen Panetz |
| Correspondent | Allen Panetz BIOCHEMICAL DIAGNOSTIC, INC. 180 HEARTLAND BLVD. Brentwood, NY 11717 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-09 |
| Decision Date | 2005-03-29 |
| Summary: | summary |