The following data is part of a premarket notification filed by Dade Chemistry Systems, Inc. with the FDA for Prostate Specific Antigen (psa) Calibrator.
| Device ID | K973100 |
| 510k Number | K973100 |
| Device Name: | PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DADE CHEMISTRY SYSTEMS, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE CHEMISTRY SYSTEMS, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-19 |
| Decision Date | 1997-09-29 |
| Summary: | summary |