The following data is part of a premarket notification filed by Eg&g Berthold Analytical Instruments, Inc. with the FDA for Berthold Lb 954.
Device ID | K922329 |
510k Number | K922329 |
Device Name: | BERTHOLD LB 954 |
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 | 1992-05-12 |
Decision Date | 1992-11-16 |