The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Counter Model S-plus Stkr.
Device ID | K871837 |
510k Number | K871837 |
Device Name: | COULTER COUNTER MODEL S-PLUS STKR |
Classification | Counter, Differential Cell |
Applicant | COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
Contact | Richardson-jones |
Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-12 |
Decision Date | 1987-07-02 |