Product code GGL
- Device name
- Control, White-Cell
- 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 |
|---|---|---|---|
| K083926 | CD4 COUNT | Streck | 2009-02-11 |
| K051633 | CD-CHEX PLUS BC | Streck | 2005-08-16 |
| K993126 | CD-CHEX CD 34 | Streck Laboratories, Inc. | 1999-11-26 |
| K960894 | CD-CHEX + RBC | Streck Laboratories, Inc. | 1996-05-24 |
| K931825 | CD-CHEX CD4 LOW | Streck Laboratories, Inc. | 1994-06-06 |
| K920997 | CD-CHEX | Streck Laboratories, Inc. | 1992-05-31 |
| K894651 | COULTER POSITIVE CONTROL CELLS | Coulter Corp. | 1989-09-13 |
| K891175 | EDL ABNORMAL COAGULATION CONTROL | Elite Diagnostic , Ltd. | 1989-04-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 40844509000141 | CD-Chex Plus | STRECK, INC. | 2016-12-01 |
| 40844509000134 | CD-Chex Plus | STRECK, INC. | 2016-12-01 |
| 15099590541972 | CYTO-TROL CONTROL CELLS | Beckman Coulter, Inc. | 2016-09-23 |
| 30844509000137 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 00844509000129 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 00844509000112 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 00844509000105 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 40844509000523 | CD-Chex Plus BC | STRECK, INC. | 2016-09-16 |
| 40844509000516 | CD-Chex Plus BC | STRECK, INC. | 2016-09-16 |
| 40844509000080 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 30844509000526 | CD-Chex Plus BC | STRECK, INC. | 2016-09-16 |
| 30844509000519 | CD-Chex Plus BC | STRECK, INC. | 2016-09-16 |
| 30844509000489 | CD-Chex CD34 | STRECK, INC. | 2016-09-16 |
| 30844509000472 | CD-Chex CD34 | STRECK, INC. | 2016-09-16 |
| 30844509000465 | CD-Chex CD34 | STRECK, INC. | 2016-09-16 |
| 30844509000144 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 10844509000089 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 30844509000090 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 30844509000083 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 20844509000529 | CD-Chex Plus BC | STRECK, INC. | 2016-09-16 |
| 20844509000512 | CD-Chex Plus BC | STRECK, INC. | 2016-09-16 |
| 20844509000482 | CD-Chex CD34 | STRECK, INC. | 2016-09-16 |
| 20844509000475 | CD-Chex CD34 | STRECK, INC. | 2016-09-16 |
| 20844509000468 | CD-Chex CD34 | STRECK, INC. | 2016-09-16 |
| 20844509000147 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 20844509000130 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 20844509000093 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 20844509000086 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 10844509000096 | CD-Chex Plus | STRECK, INC. | 2016-09-16 |
| 00382903409914 | N/A | Becton, Dickinson And Company | 2016-06-08 |