Whole Blood Gas Control, Levels 1,2,&3
FDA 510(k) K800296 · Dade, Baxter Travenol Diagnostics, Inc.
510(k) numberK800296
Submission
- Device name
- Whole Blood Gas Control, Levels 1,2,&3
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US - Received
- February 11, 1980
- Decision date
- March 5, 1980
- 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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| 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 |
More from Direct Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K792606 | Whole Blood Platelet Control Normal,JPK · Traditional | 02/13/1980SE |
| K792723 | Blood Fluid FiltersJKA · Traditional | 01/21/1980SE |
| K792607 | T3 Uptake (T3U) ReagentsKHQ · Traditional | 01/16/1980SE |
| K792443 | TSH RadioimmunoassayJLW · Traditional | 12/27/1979SE |
| K792442 | Ferritin RadioimmunoassayDBF · Traditional | 12/18/1979SE |
| K791922 | Harleco Brand Clinicard Lipase Test SetCET · Traditional | 11/27/1979SE |
| K792183 | Dade High Density Lipoprotein CholesteroLBS · Traditional | 11/13/1979SE |
| K790776 | Dade Low Ionic Strength Soluition (Liss)KSG · Traditional | 05/23/1979SE |
| K790767 | Immu-Tek Automatic CentrifugeKSN · Traditional | 05/23/1979SE |
| K790571 | Quik-StainIAF · Traditional | 04/23/1979SE |
Questions and answers
When was Whole Blood Gas Control, Levels 1,2,&3 cleared by the FDA?
Whole Blood Gas Control, Levels 1,2,&3 (K800296) received a 510(k) decision of Substantially Equivalent on March 5, 1980, 23 days after the submission was received.
What is the product code of K800296?
The FDA product code is GGM – Control, Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.8625.