GIF — Diluent, Blood Cell Class I
FDA Device Classification
Classification Details
- Product Code
- GIF
- Device Class
- Class I
- Regulation Number
- 864.8200
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K883989 | kvm technologies | KVM ISOTONIC FLUSH SOLUTION | October 12, 1988 |
| K883990 | kvm technologies | KVM ISOTONIC DILUENT | October 12, 1988 |
| K882490 | r and d systems | HYCEL QUICK-LYSING HEMOGLOBIN REAGENT | July 25, 1988 |
| K882267 | toa medical electronics usa | SYSMEX QUICKLYSER-II (QLS-200A) | July 12, 1988 |
| K881130 | abbott diagnostics | CELL-DYN ISOTONIC DILUENT | March 31, 1988 |
| K873347 | abbott diagnostics | CELL-DYN DIFF. SCREEN ISOTONIC DILUENT | September 9, 1987 |
| K851843 | hematology marketing assoc | OSMOCEL 3 | July 30, 1985 |
| K851320 | scientific distributors | SDI PREPAX DILUKIT M. | July 5, 1985 |
| K851280 | dass | DASS PACK | July 5, 1985 |
| K850239 | toa medical electronics usa | SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- | April 1, 1985 |
| K850095 | hematology marketing assoc | LASER-DIL | March 29, 1985 |
| K844782 | nobel scientific industries | NSI ELT-D DILUTING FLUID 4000ML | March 5, 1985 |
| K842929 | e k ind | HAYEM DILUTING FLUID | September 7, 1984 |
| K842068 | interscience diagnostics | IDI ISOTONIC DILUENT | July 2, 1984 |
| K841799 | reagent laboratory | CYANOMETHEMOGLOBIN REAGENT | May 31, 1984 |
| K840041 | scientific distributors | SDI PREPAX DILUKIT HW | March 5, 1984 |
| K840477 | emd chemicals | UNITIZED HEMATOLOGY SET 65132/93 | March 5, 1984 |
| K833972 | seragen diagnostics | QUICK-COUNT HEMATOLOGY REAGENT KIT | February 17, 1984 |
| K840043 | scientific distributors | SDI PREPAX DILUKIT CT | February 10, 1984 |
| K840038 | scientific distributors | PREPAX DILUKIT PLUS | February 10, 1984 |