510(k) K111211
- Device
- CELL-DYN 22 PLUS CONTROL
- Applicant
- Streck
- 510(k) number
- K111211
- Product code
- GLQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-12-22
- Date received
- 2011-04-29
- Regulation
- 864.8625
- Classification name
- Mixture, Control, White-cell And Red-cell Indices
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Deborah Kipp
- Address
- 7002 S 109th St. La Vista NE US 68128 68128
FDA Registration Numbers#
- 9613959
- 3014150341
- 3016438761
- 3009711478
- 1950302
- 3005333358
- 3003741796
Source Documents#
Other 510(k) Records For Product Code GLQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary