Product code GIF
- Device name
- Diluent, Blood Cell
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.8200
- 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 |
|---|---|---|---|
| K883990 | KVM ISOTONIC DILUENT | Kvm Technologies, Inc. | 1988-10-12 |
| K883989 | KVM ISOTONIC FLUSH SOLUTION | Kvm Technologies, Inc. | 1988-10-12 |
| K882490 | HYCEL QUICK-LYSING HEMOGLOBIN REAGENT | R&D Systems, Inc. | 1988-07-25 |
| K882267 | SYSMEX QUICKLYSER-II (QLS-200A) | Toa Medical Electronics USA, Inc. | 1988-07-12 |
| K881130 | CELL-DYN ISOTONIC DILUENT | Abbott Diagnostics | 1988-03-31 |
| K873347 | CELL-DYN DIFF. SCREEN ISOTONIC DILUENT | Abbott Diagnostics | 1987-09-09 |
| K851843 | OSMOCEL 3 | Hematology Marketing Assoc. | 1985-07-30 |
| K851320 | SDI PREPAX DILUKIT M. | Scientific Distributors, Inc. | 1985-07-05 |
| K851280 | DASS PACK | Dass, Inc. | 1985-07-05 |
| K850239 | SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- | Toa Medical Electronics USA, Inc. | 1985-04-01 |
| K850095 | LASER-DIL | Hematology Marketing Assoc. | 1985-03-29 |
| K844782 | NSI ELT-D DILUTING FLUID 4000ML | Nobel Scientific Industries, Inc. | 1985-03-05 |
| K842929 | HAYEM DILUTING FLUID | E K Ind., Inc. | 1984-09-07 |
| K842068 | IDI ISOTONIC DILUENT | Interscience Diagnostics, Inc. | 1984-07-02 |
| K841799 | CYANOMETHEMOGLOBIN REAGENT | Reagent Laboratory, Inc. | 1984-05-31 |
| K840477 | UNITIZED HEMATOLOGY SET 65132/93 | Emd Chemicals, Inc. | 1984-03-05 |
| K840041 | SDI PREPAX DILUKIT HW | Scientific Distributors, Inc. | 1984-03-05 |
| K833972 | QUICK-COUNT HEMATOLOGY REAGENT KIT | Seragen Diagnostics, Inc. | 1984-02-17 |
| K840038 | PREPAX DILUKIT PLUS | Scientific Distributors, Inc. | 1984-02-10 |
| K840043 | SDI PREPAX DILUKIT CT | Scientific Distributors, Inc. | 1984-02-10 |
| K833443 | ISOTONIC BLOOD CELL DILUENT J & S | Jasins & Sayles Associates, Inc. | 1983-11-03 |
| K832116 | ATAC 4700 HEMATOLOGY CELL COUNTER | Turpen Laboratory Systems, Inc. | 1983-10-20 |
| K831617 | DILUENT | Omega Medical Diagnostics | 1983-06-16 |
| K830188 | OSMOCEL + | Hematology Marketing Assoc. | 1983-03-01 |
| K822325 | BLOOD CELL DILUENT 78N 1913 | Interscience, Inc. | 1982-10-18 |
| K822501 | CDL ISOTONIC DILUENT | Connecticut Diagnostics, Ltd. | 1982-09-17 |
| K821683 | REAGENT FOR COULTER COUNTER MODEL 5+11 | Fisher Scientific Co., LLC | 1982-06-24 |
| K812309 | CRYOSAN NORMAL SALINE | Cryosan, Inc. | 1981-09-16 |
| K801357 | MODIFIED BLOOD CELL COUNTING & LYSING | Coulter Electronics, Inc. | 1980-08-14 |
| K801346 | NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA | Nobel Scientific Industries, Inc. | 1980-08-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414289960 | Atellica HEMA Diluent | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 00630414289953 | Atellica HEMA Diluent | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 14562185399681 | CL AIA-PACK Progesterone SAMPLE DILUTING REAGENT | TOSOH CORPORATION | 2025-09-01 |
| 24562185395390 | CL AIA-PACK SAMPLE DILUTING REAGENT A | TOSOH CORPORATION | 2025-09-01 |
| 14562185399650 | CL AIA-PACK SAMPLE DILUTING REAGENT D | TOSOH CORPORATION | 2025-09-01 |
| 14562185395393 | CL AIA-PACK SAMPLE DILUTING REAGENT A | TOSOH CORPORATION | 2025-09-01 |
| 06944904093178 | M-53D Diluent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-01-17 |
| 06903053010702 | M-30D Diluent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-01-17 |
| 00630414237701 | Atellica Multi-Diluent 15 | Siemens Healthcare Diagnostics Inc. | 2023-06-02 |
| 10758750005024 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2023-05-12 |
| 04987562433940 | UF-CELLPACK CR | SYSMEX CORPORATION | 2022-11-30 |
| 04987562433933 | UF-CELLPACK SF | SYSMEX CORPORATION | 2022-11-30 |
| 04987562432387 | CELLPACK DFL | SYSMEX CORPORATION | 2022-11-30 |
| 04987562422951 | CELLPACK DFL | SYSMEX CORPORATION | 2022-11-30 |
| 04987562422944 | CELLPACK DST | SYSMEX CORPORATION | 2022-11-30 |
| 04987562408382 | UF II PACK-SED | SYSMEX CORPORATION | 2022-11-30 |
| 04987562408399 | UF II PACK-BAC | SYSMEX CORPORATION | 2022-11-30 |
| 10664369999879 | UF II PACK-BAC | SYSMEX CORPORATION | 2022-11-04 |
| 10664369000643 | XW pack D | SYSMEX CORPORATION | 2022-11-04 |
| 10664369000681 | UF-Cellpack CR | SYSMEX CORPORATION | 2022-11-04 |
| 10664369000698 | UF-Cellpack SF | SYSMEX CORPORATION | 2022-11-04 |
| 10664369402553 | pocH-pack D | SYSMEX CORPORATION | 2022-11-04 |
| 10664369999862 | UF II PACK-SED | SYSMEX CORPORATION | 2022-11-04 |
| 10840199506542 | Needle Holder | KOROS U.S.A., INC. | 2022-04-01 |
| 10840199506474 | Needle Holder | KOROS U.S.A., INC. | 2022-04-01 |
| 10840199505781 | Needle Holder | KOROS U.S.A., INC. | 2022-04-01 |
| 10885380162473 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-04-19 |
| 20630140008495 | SP | Cardinal Health 200, LLC | 2018-12-27 |
| 00380740120788 | CELL-DYN | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740020156 | CELL-DYN | ABBOTT LABORATORIES | 2016-06-06 |