R&D SICKLE QC CONTROL
FDA 510(k) clearance K070334 · decided 2007-03-29
Clearance details
- K-number
- K070334
- Device name
- R&D SICKLE QC CONTROL
- Applicant
- R&D Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-02-05
- Decision date
- 2007-03-29
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- GGM
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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| GLYCOHEMOSURE HBA1C CONTROL (K032791) | Quantimetrix Corp. | 2003-10-30 |
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| R&D HGB/GLC WHOLE BLOOD CONTROL (K993321) | R&D Systems, Inc. | 1999-11-12 |
| HEMOCUE HEMOTROL (K964052) | Direct Solutions | 1996-11-06 |
| HEMOCUE HEMOLIN (K963908) | Direct Solutions | 1996-10-16 |
| CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL (K921681) | Isolab, Inc. | 1992-11-17 |
| HGB-CONTROL SET/MULTIPLE (K893985) | R&D Systems, Inc. | 1989-08-15 |
| PRECINORM HB (K852136) | Boehringer Mannheim Corp. | 1985-07-05 |
Recalls involving this device
No recalls on record reference this clearance.