Whole Blood Gas Control
FDA 510(k) K770950 · Dade, Baxter Travenol Diagnostics, Inc.
510(k) numberK770950
Submission
- Device name
- Whole Blood Gas Control
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US - Received
- May 25, 1977
- Decision date
- August 2, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJS – Controls For Blood-Gases, (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152553 | CueSee HypoxicJJS · Traditional | Eurotrol B.V. | 04/22/2016SE |
| K150226 | Hematocrit and Metabolite QUALICHECKJJS · Traditional | Radiometer Medical Aps | 05/13/2015SE |
| K130415 | High Metabolite QualicheckJJS · Traditional | Radiometer Medical Aps | 03/26/2013SE |
| K130236 | Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3JJS · Traditional | Radiometer Medical Aps | 03/15/2013SE |
| K033063 | Mission ControlsJJS · Traditional | Diamond Diagnostics, Inc. | 12/12/2003SE |
| K022529 | Liquichek Blood Gas Plus Co-Oximeter Control (Il Synthesis Series) Levels 1,2, and 3…JJS · Traditional | Bio-Rad | 08/15/2002SE |
| K022525 | Liquichek Blood Gas Plus Co-Oximeter Control (Radiometer 700 Series) Levels, 1,2 and 3…JJS · Traditional | Bio-Rad | 08/15/2002SE |
| K003242 | Liquichek Blood Gas Plus Co-Oximeter Control (Il), Model 621,622,623JJS · Traditional | Bio-Rad | 11/30/2000SE |
| K003239 | Liquichek Blood Gas Plus Co-Oximeter Control (800 Series), MODEL504,505,506JJS · Traditional | Bio-Rad | 11/30/2000SE |
| K002866 | Liquichek Blood Gas Plus E Control Level 4, Model 574JJS · Traditional | Bio-Rad | 09/25/2000SE |
More from Bio-Rad
| 510(k) | Device | Decision |
|---|---|---|
| K800296 | Whole Blood Gas Control, Levels 1,2,&3GGM · Traditional | 03/05/1980SE |
| 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 |
Questions and answers
When was Whole Blood Gas Control cleared by the FDA?
Whole Blood Gas Control (K770950) received a 510(k) decision of Substantially Equivalent on August 2, 1977, 69 days after the submission was received.
What is the product code of K770950?
The FDA product code is JJS – Controls For Blood-Gases, (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.