The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Coulter Clone Quick Stain Whole Blood Lyse-ii.
| Device ID | K883836 |
| 510k Number | K883836 |
| Device Name: | COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II |
| Classification | Products, Red-cell Lysing Products |
| Applicant | COULTER IMMUNOLOGY 440 COULTER WAY WEST 20TH STREET Hialeah, FL 33010 |
| Contact | Lee C Matthews |
| Correspondent | Lee C Matthews COULTER IMMUNOLOGY 440 COULTER WAY WEST 20TH STREET Hialeah, FL 33010 |
| Product Code | GGK |
| CFR Regulation Number | 864.8540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-12 |
| Decision Date | 1988-11-30 |