510(k) K083926
- Device
- CD4 COUNT
- Applicant
- Streck
- 510(k) number
- K083926
- Product code
- GGL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-02-11
- Date received
- 2008-12-31
- Regulation
- 864.8625
- Classification name
- Control, White-Cell
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- KERRIE OETTER
- Address
- 7002 S 109th St. La Vista NE US 68128 68128
FDA Registration Numbers
- 1061932
- 3014150341
- 1017835
- 3027394506
- 1950302
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GGL
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |