The following data is part of a premarket notification filed by Serono-baker Diagnostics, Inc. with the FDA for Sr1 System Automated Photometric Analyzer.
| Device ID | K883539 |
| 510k Number | K883539 |
| Device Name: | SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | SERONO-BAKER DIAGNOSTICS, INC. P.O. BOX 2867 3085 SHAWNEE DRIVE Winchester, VA 22601 |
| Contact | Richard Tomalesky |
| Correspondent | Richard Tomalesky SERONO-BAKER DIAGNOSTICS, INC. P.O. BOX 2867 3085 SHAWNEE DRIVE Winchester, VA 22601 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-16 |
| Decision Date | 1988-10-31 |