Hgb-Control Set/Multiple
FDA 510(k) K893985 · R&D Systems, Inc.
510(k) numberK893985
Submission
- Device name
- Hgb-Control Set/Multiple
- Applicant
- R&D Systems, Inc.
Minneapolis, MN, US - Received
- June 5, 1989
- Decision date
- August 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGM – Control, Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
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|---|---|---|---|
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighGGM · Traditional | Eurotrol B.V. | 11/15/2019SE |
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighGGM · Traditional | Eurotrol B.V. | 02/01/2019SE |
| K070546 | Lyphochek Diabetes ControlGGM · Traditional | Bio-Rad Laboratories | 04/02/2007SE |
| K070334 | R&D Sickle QC ControlGGM · Traditional | R&D Systems, Inc. | 03/29/2007SE |
| K052838 | Liquichek Diabetes Control, Level 1,2,3,4GGM · Traditional | Bio-Rad | 11/09/2005SE |
| K032791 | Glycohemosure HBA1C ControlGGM · Traditional | Quantimetrix Corp. | 10/30/2003SE |
| K003030 | Lyphochek Hemoglobin Alc Linearity SetGGM · Traditional | Bio-Rad | 11/29/2000SE |
| K993321 | R&D Hgb/Glc Whole Blood ControlGGM · Traditional | R&D Systems, Inc. | 11/12/1999SE |
| K964052 | Hemocue HemotrolGGM · Traditional | Direct Solutions | 11/06/1996SE |
| K963908 | Hemocue HemolinGGM · Traditional | Direct Solutions | 10/16/1996SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K160606 | BC-5D Hematology ControlJPK · Traditional | 09/01/2016SE |
| K130962 | R&D 5D Retic Hematology ControlJPK · Special | 07/24/2013SE |
| K101578 | R&D Systems Body Fluid-I Hematology ControlJPK · Traditional | 04/28/2011SE |
| K100050 | R & D Systems Xeret Hematology ControlJPK · Special | 01/29/2010SE |
| K091433 | R&D Systems Tetic-I Plus Hemotology ControlJPK · Special | 10/28/2009SE |
| K073178 | HCT Extended Hematology Control, Model HCT004JPK · Traditional | 12/27/2007SE |
| K072846 | CSF Automated Control, Models CSF001, CSF003JPK · Traditional | 11/26/2007SE |
| K072268 | HC WBC Hematology Control, Model: WBC00SJPK · Traditional | 11/20/2007SE |
| K072096 | CBC-5D Plus Retics Hematology Control, Models: 5DR03, 5DR04JPK · Special | 08/20/2007SE |
| K070334 | R&D Sickle QC ControlGGM · Traditional | 03/29/2007SE |
Questions and answers
When was Hgb-Control Set/Multiple cleared by the FDA?
Hgb-Control Set/Multiple (K893985) received a 510(k) decision of Substantially Equivalent on August 15, 1989, 71 days after the submission was received.
What is the product code of K893985?
The FDA product code is GGM – Control, Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.8625.