The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Retic-c Cell Control.
| Device ID | K930119 |
| 510k Number | K930119 |
| Device Name: | COULTER RETIC-C CELL CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | COULTER ELECTRONICS, INC. 600 WEST 20TH ST. Hialeah, FL 33010 |
| Contact | Benita Bradford |
| Correspondent | Benita Bradford COULTER ELECTRONICS, INC. 600 WEST 20TH ST. Hialeah, FL 33010 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-12 |
| Decision Date | 1993-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590233785 | K930119 | 000 |
| 15099590231026 | K930119 | 000 |
| 15099590230395 | K930119 | 000 |
| 15099590221119 | K930119 | 000 |