The following data is part of a premarket notification filed by Eg&g Berthold Analytical Instruments, Inc. with the FDA for Lb 9502- Clinilumat, Lb 953 - Auto-climilumat.
| Device ID | K922976 |
| 510k Number | K922976 |
| Device Name: | LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | EG&G BERTHOLD ANALYTICAL INSTRUMENTS, INC. 472 AMHERST ST. Nashua, NH 03063 |
| Contact | Michael S Cianci |
| Correspondent | Michael S Cianci EG&G BERTHOLD ANALYTICAL INSTRUMENTS, INC. 472 AMHERST ST. Nashua, NH 03063 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-29 |
| Decision Date | 1992-11-16 |