GGK — Products, Red-Cell Lysing Products Class I
FDA product code GGK covers "Products, Red-Cell Lysing Products", a Class I medical device regulated under 21 CFR 864.8540. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GGK
- Device Class
- Class I
- Regulation Number
- 864.8540
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K883836 | coulter immunology | COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II | November 30, 1988 |
| K883991 | kvm technologies | KVM HEMOGLOBIN LYSING REAGENT | October 12, 1988 |
| K874054 | fisher scientific co | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | October 20, 1987 |
| K873348 | abbott diagnostics | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. | September 9, 1987 |
| K863114 | j. d. assoc | PIASTRINIT | November 6, 1986 |
| K863503 | reagent laboratory | HEMOLYSE | October 3, 1986 |
| K850097 | hematology marketing assoc | LASER-LYSE | March 29, 1985 |
| K850944 | nobel scientific industries | NSI LYSING-D REAGENT -4000 ML | March 29, 1985 |
| K842938 | e k ind | ACETIC ACID 1% V/V | September 14, 1984 |
| K842936 | e k ind | ACETIC ACID, 3% V/V | September 12, 1984 |
| K842935 | e k ind | ACETIC ACID, 5% V/V | September 12, 1984 |
| K842937 | e k ind | ACETIC ACID 2% V/V | September 12, 1984 |
| K842069 | interscience diagnostics | IDL-LYSING REAGENT | July 2, 1984 |
| K841800 | reagent laboratory | LYSING & HEMOGLOBIN REAGENT | May 31, 1984 |
| K840289 | medilab | LYSE-TEC | March 5, 1984 |
| K834527 | w. sarstedt | THROMBO PLUS | January 30, 1984 |
| K833444 | jasins and sayles associates | LYSING & HEMOGLOBIN S-REAGENT J & S | November 3, 1983 |
| K832182 | omega medical diagnostics | LYSING REAGENT | August 12, 1983 |
| K830186 | hematology marketing assoc | LYSIS + | February 28, 1983 |
| K822324 | interscience | RED CELL LYSING REAGENT 78N 1915-1 | November 8, 1982 |