The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Model 690 Spectrophotometer.
Device ID | K873408 |
510k Number | K873408 |
Device Name: | MODEL 690 SPECTROPHOTOMETER |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
Contact | Alan B Fowler |
Correspondent | Alan B Fowler ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-25 |
Decision Date | 1987-09-08 |