The following data is part of a premarket notification filed by Berthold Analytical Instruments, Inc. with the FDA for Berthold Lb 2103,2104-xt/pc/at,951g Gamma Counters.
| Device ID | K870115 |
| 510k Number | K870115 |
| Device Name: | BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS |
| Classification | Counter (beta, Gamma) 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 | JJJ |
| CFR Regulation Number | 862.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-12 |
| Decision Date | 1987-03-31 |