The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Counter Model S-plus V.
Device ID | K833600 |
510k Number | K833600 |
Device Name: | COULTER COUNTER MODEL S-PLUS V |
Classification | Counter, Differential Cell |
Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-12 |
Decision Date | 1984-01-10 |