XE CHECK
FDA 510(k) clearance K994388 · decided 2000-01-14
Clearance details
- K-number
- K994388
- Device name
- XE CHECK
- Applicant
- Streck Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-28
- Decision date
- 2000-01-14
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- GLQ
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Omaha, NE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CELL-DYN 22 PLUS CONTROL (K111211) | Streck | 2011-12-22 |
| CELL-CHEX WITH CPPD CRYSTALS (K110718) | Streck | 2011-05-26 |
| CELL-CHEX (K101335) | Streck | 2010-08-23 |
| STAK-CHEX PLUS RETICS (K090137) | Streck | 2009-03-18 |
| PARA 12 PLUS RETICS (K000945) | Streck Laboratories, Inc. | 2000-04-18 |
| STAK-CHEX PLUS RETICS (K992887) | Streck Laboratories, Inc. | 1999-11-22 |
| CONTROL TM 8 (K823794) | General Diagnostics | 1983-01-14 |
| UNI-CELL (K823587) | Medical Specialties Laboratories | 1983-01-05 |
| PARA 12 (K823498) | Streck Laboratories, Inc. | 1982-12-28 |
Recalls involving this device
No recalls on record reference this clearance.