Product code GLQ
- Device name
- Mixture, Control, White-Cell And Red-Cell Indices
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.8625
- 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 |
|---|---|---|---|
| K111211 | CELL-DYN 22 PLUS CONTROL | Streck | 2011-12-22 |
| K110718 | CELL-CHEX WITH CPPD CRYSTALS | Streck | 2011-05-26 |
| K101335 | CELL-CHEX | Streck | 2010-08-23 |
| K090137 | STAK-CHEX PLUS RETICS | Streck | 2009-03-18 |
| K000945 | PARA 12 PLUS RETICS | Streck Laboratories, Inc. | 2000-04-18 |
| K994388 | XE CHECK | Streck Laboratories, Inc. | 2000-01-14 |
| K992887 | STAK-CHEX PLUS RETICS | Streck Laboratories, Inc. | 1999-11-22 |
| K823794 | CONTROL TM 8 | General Diagnostics | 1983-01-14 |
| K823587 | UNI-CELL | Medical Specialties Laboratories | 1983-01-05 |
| K823498 | PARA 12 | Streck Laboratories, Inc. | 1982-12-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740151270 | Alinity | Abbott GmbH | 2023-11-16 |
| 00380740151287 | Alinity | Abbott GmbH | 2023-11-16 |
| 14987562460561 | e-CHECK(XS) | SYSMEX CORPORATION | 2017-10-06 |
| 20844509000345 | STaK-Chex Plus Retics | STRECK, INC. | 2016-09-19 |
| 00844509000358 | STaK-Chex Plus Retics | STRECK, INC. | 2016-09-19 |
| 00844509000365 | STaK-Chex Plus Retics | STRECK, INC. | 2016-09-19 |
| 30844509000335 | STaK-Chex Plus Retics | STRECK, INC. | 2016-09-19 |
| 20844509000338 | STaK-Chex Plus Retics | STRECK, INC. | 2016-09-19 |
| 20844509000321 | STaK-Chex Plus Retics | STRECK, INC. | 2016-09-19 |
| 20844509000277 | Cell-Chex | STRECK, INC. | 2016-09-16 |
| 30844509000267 | Cell-Chex | STRECK, INC. | 2016-09-16 |
| 20844509000260 | Cell-Chex | STRECK, INC. | 2016-09-16 |
| 20844509000253 | Cell-Chex | STRECK, INC. | 2016-09-16 |
| 00844509000303 | Cell-Chex | STRECK, INC. | 2016-09-16 |
| 00844509000297 | Cell-Chex | STRECK, INC. | 2016-09-16 |
| 00844509000280 | Cell-Chex | STRECK, INC. | 2016-09-16 |
| 30844509000632 | Para 12 Extend | STRECK, INC. | 2016-09-14 |
| 00844509000662 | Para 12 Extend | STRECK, INC. | 2016-09-14 |
| 00844509000655 | Para 12 Extend | STRECK, INC. | 2016-09-14 |
| 00844509000648 | Para 12 Extend | STRECK, INC. | 2016-09-14 |
| 00844509000679 | Para 12 Extend | STRECK, INC. | 2016-09-14 |
| 50844509000612 | Para 12 Extend | STRECK, INC. | 2016-09-14 |
| 40844509000639 | Para 12 Extend | STRECK, INC. | 2016-09-14 |
| 40844509000622 | Para 12 Extend | STRECK, INC. | 2016-09-14 |
| 40844509000615 | Para 12 Extend | STRECK, INC. | 2016-09-14 |
| 30844509000625 | Para 12 Extend | STRECK, INC. | 2016-09-14 |
| 30844509000618 | Para 12 Extend | STRECK, INC. | 2016-09-14 |
| 14987562460288 | e-CHECK | SYSMEX CORPORATION | 2016-08-05 |
| 14987562460578 | e-CHECK(XS) | SYSMEX CORPORATION | 2016-08-05 |
| 00380740017088 | CELL-DYN | ABBOTT LABORATORIES | 2016-06-06 |