The following data is part of a premarket notification filed by Berthold Analytical Instruments, Inc. with the FDA for Lb 9502 - Clinilumat, Lb 952 - Auto-clinilumat.
| Device ID | K872324 |
| 510k Number | K872324 |
| Device Name: | LB 9502 - CLINILUMAT, LB 952 - AUTO-CLINILUMAT |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | BERTHOLD ANALYTICAL INSTRUMENTS, INC. 28 CHARRON AVE. Nashua, NH 03063 |
| Contact | Max E Tyrrell |
| Correspondent | Max E Tyrrell BERTHOLD ANALYTICAL INSTRUMENTS, INC. 28 CHARRON AVE. 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 | 1987-06-17 |
| Decision Date | 1987-08-19 |