HEMOGLOBIN CONTROLS
FDA 510(k) clearance K790310 · decided 1979-03-21
Clearance details
- K-number
- K790310
- Device name
- HEMOGLOBIN CONTROLS
- Applicant
- Electrophoresis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-13
- Decision date
- 1979-03-21
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- GGM
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (K192842) | Eurotrol B.V. | 2019-11-15 |
| HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (K182744) | Eurotrol B.V. | 2019-02-01 |
| LYPHOCHEK DIABETES CONTROL (K070546) | Bio-Rad Laboratories | 2007-04-02 |
| R&D SICKLE QC CONTROL (K070334) | R&D Systems, Inc. | 2007-03-29 |
| LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 (K052838) | Bio-Rad | 2005-11-09 |
| GLYCOHEMOSURE HBA1C CONTROL (K032791) | Quantimetrix Corp. | 2003-10-30 |
| LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET (K003030) | Bio-Rad | 2000-11-29 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.