Control, Hemoglobin
Control, Hemoglobin (product code GGM) is a quality control material used to calibrate and monitor the performance of laboratory instruments measuring hemoglobin concentrations in blood, supporting reliable diagnosis of anemia and related conditions. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.8625 in the Hematology specialty (HE), this device carries no special regulatory flags.
Basic Information
- Product Code
- GGM
- Device Class
- FDA class 2
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | Nov 15, 2019 | Substantially Equivalent | Eurotrol B.V. |
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | Feb 01, 2019 | Substantially Equivalent | EUROTROL B.V. |
| K070546 | LYPHOCHEK DIABETES CONTROL | Apr 02, 2007 | Substantially Equivalent | Bio-Rad Laboratories |
| K070334 | R&D SICKLE QC CONTROL | Mar 29, 2007 | Substantially Equivalent | R & D SYSTEMS, INC. |
| K052838 | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 | Nov 09, 2005 | Substantially Equivalent | BIO-RAD |
| K032791 | GLYCOHEMOSURE HBA1C CONTROL | Oct 30, 2003 | Substantially Equivalent | QUANTIMETRIX CORP. |
| K003030 | LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET | Nov 29, 2000 | Substantially Equivalent | BIO-RAD |
| K993321 | R&D HGB/GLC WHOLE BLOOD CONTROL | Nov 12, 1999 | Substantially Equivalent | R & D SYSTEMS, INC. |
| K964052 | HEMOCUE HEMOTROL | Nov 06, 1996 | Substantially Equivalent | DIRECT SOLUTIONS |
| K963908 | HEMOCUE HEMOLIN | Oct 16, 1996 | Substantially Equivalent | DIRECT SOLUTIONS |
| K921681 | CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL | Nov 17, 1992 | Substantially Equivalent | ISOLAB, INC. |
| K893985 | HGB-CONTROL SET/MULTIPLE | Aug 15, 1989 | Substantially Equivalent | R & D SYSTEMS, INC. |
| K852136 | PRECINORM HB | Jul 05, 1985 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K800296 | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 | Mar 05, 1980 | Substantially Equivalent | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. |
| K790310 | HEMOGLOBIN CONTROLS | Mar 21, 1979 | Substantially Equivalent | ELECTROPHORESIS CORP. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.