R&D HGB/GLC WHOLE BLOOD CONTROL
FDA 510(k) clearance K993321 · decided 1999-11-12
Clearance details
- K-number
- K993321
- Device name
- R&D HGB/GLC WHOLE BLOOD CONTROL
- Applicant
- R&D Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-04
- Decision date
- 1999-11-12
- Days to decision
- 39 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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| HEMOCUE HEMOTROL (K964052) | Direct Solutions | 1996-11-06 |
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| 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.