Product code GGK
- Device name
- Products, Red-Cell Lysing Products
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.8540
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883836 | COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II | Coulter Immunology | 1988-11-30 |
| K883991 | KVM HEMOGLOBIN LYSING REAGENT | Kvm Technologies, Inc. | 1988-10-12 |
| K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | Fisher Scientific Co., LLC | 1987-10-20 |
| K873348 | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. | Abbott Diagnostics | 1987-09-09 |
| K863114 | PIASTRINIT | J. D. Assoc. | 1986-11-06 |
| K863503 | HEMOLYSE | Reagent Laboratory, Inc. | 1986-10-03 |
| K850944 | NSI LYSING-D REAGENT -4000 ML | Nobel Scientific Industries, Inc. | 1985-03-29 |
| K850097 | LASER-LYSE | Hematology Marketing Assoc. | 1985-03-29 |
| K842938 | ACETIC ACID 1% V/V | E K Ind., Inc. | 1984-09-14 |
| K842937 | ACETIC ACID 2% V/V | E K Ind., Inc. | 1984-09-12 |
| K842936 | ACETIC ACID, 3% V/V | E K Ind., Inc. | 1984-09-12 |
| K842935 | ACETIC ACID, 5% V/V | E K Ind., Inc. | 1984-09-12 |
| K842069 | IDL-LYSING REAGENT | Interscience Diagnostics, Inc. | 1984-07-02 |
| K841800 | LYSING & HEMOGLOBIN REAGENT | Reagent Laboratory, Inc. | 1984-05-31 |
| K840289 | LYSE-TEC | Medilab Corp. | 1984-03-05 |
| K834527 | THROMBO PLUS | W. Sarstedt, Inc. | 1984-01-30 |
| K833444 | LYSING & HEMOGLOBIN S-REAGENT J & S | Jasins & Sayles Associates, Inc. | 1983-11-03 |
| K832182 | LYSING REAGENT | Omega Medical Diagnostics | 1983-08-12 |
| K830186 | LYSIS + | Hematology Marketing Assoc. | 1983-02-28 |
| K822324 | RED CELL LYSING REAGENT 78N 1915-1 | Interscience, Inc. | 1982-11-08 |
| K822504 | CDL AUTO-LYSING REAGENT | Connecticut Diagnostics, Ltd. | 1982-09-17 |
| K822500 | CDL LYSING REAGENT | Connecticut Diagnostics, Ltd. | 1982-09-17 |
| K812002 | ELUAID | Ortho Diagnostic Systems, Inc. | 1981-10-28 |
| K802742 | SERA-PAK TOTAL PROTEIN REAGENT | Miles Laboratories, Inc. | 1980-12-11 |
| K790029 | FLUID, RHEMOX W LYSING | Sysmex Corp. | 1979-02-26 |
| K782098 | REAGENT, LYSING AND HEMOGLOBIN | Dade, Baxter Travenol Diagnostics, Inc. | 1979-01-17 |
| K781121 | HEMOLYSE | Electrophoresis Corp. of America | 1978-08-14 |
| K771788 | CYMET-AUTOMATED | J.T. Baker Chemical Co. | 1977-10-07 |
| K761182 | ISOTONIC DILUENT AF | Central Labs. Assoc. MD Pathologists | 1976-12-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00664369000899 | LYSERCELL WDF II | SYSMEX CORPORATION | 2026-04-24 |
| 00630414289991 | Atellica HEMA HGB | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 00630414290027 | Atellica HEMA Diff | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 04987562432325 | LYSERCELL WDF | SYSMEX CORPORATION | 2022-11-30 |
| 04987562423002 | Lysercell WPC | SYSMEX CORPORATION | 2022-11-30 |
| 04987562422999 | LYSERCELL WDF | SYSMEX CORPORATION | 2022-11-30 |
| 04987562422982 | Lysercell WNR | SYSMEX CORPORATION | 2022-11-30 |
| 04987562422975 | SULFOLYSER | SYSMEX CORPORATION | 2022-11-30 |
| 10664369000650 | XW pack L | SYSMEX CORPORATION | 2022-11-04 |
| 10664369200159 | SULFOLYSER | SYSMEX CORPORATION | 2022-11-04 |
| 10664369200548 | STROMATOLYSER-WH | SYSMEX CORPORATION | 2022-11-04 |
| 10664369402560 | pocH-pack L | SYSMEX CORPORATION | 2022-11-04 |
| 10859952006014 | Brand name | LIFE TECHNOLOGIES CORPORATION | 2018-06-02 |
| 03610230004715 | MINILYSEBIO (1L) | HORIBA ABX SAS | 2017-01-09 |
| 03610230004685 | ABX LYSEBIO (1L) | HORIBA ABX SAS | 2016-09-17 |
| 00380740120771 | CELL-DYN | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740135720 | CELL-DYN | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740135713 | CELL-DYN | ABBOTT LABORATORIES | 2016-09-09 |
| 03610230004548 | ABX MINILYSE (1L) | HORIBA ABX SAS | 2016-09-02 |
| 03610230004722 | MINILYSEBIO (0.4L) | HORIBA ABX SAS | 2016-09-02 |
| 03610230004456 | ABX LEUCODIFF 1L | HORIBA ABX SAS | 2016-08-23 |
| 03610230004432 | ABX EOSINOFIX (1L) | HORIBA ABX SAS | 2016-08-23 |
| 03610230004555 | ABX MINILYSE LMG (1L) | HORIBA ABX SAS | 2016-08-16 |
| 03610230004654 | ABX BASOLYSE II | HORIBA ABX SAS | 2016-08-16 |
| 03610230004661 | ABX ALPHALYSE (0.4L) | HORIBA ABX SAS | 2016-08-16 |
| 03610230004692 | ABX LYSEBIO (0.4L) | HORIBA ABX SAS | 2016-08-16 |
| 03610230004708 | ABX ALPHALYSE (360mL) | HORIBA ABX SAS | 2016-08-16 |
| 03610230004746 | WHITEDIFF (1L) | HORIBA ABX SAS | 2016-08-16 |
| 00380740020149 | CELL-DYN | ABBOTT LABORATORIES | 2016-06-06 |
| 03610230004425 | ABX BASOLYSE | HORIBA ABX SAS | 2016-05-02 |