Multi Function Blood Gas Control
FDA 510(k) K851911 · Bionostics, Inc.
510(k) numberK851911
Submission
- Device name
- Multi Function Blood Gas Control
- Applicant
- Bionostics, Inc.
Acton, MA, US - Received
- May 1, 1985
- Decision date
- May 20, 1985
- 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
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| 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 |
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Questions and answers
When was Multi Function Blood Gas Control cleared by the FDA?
Multi Function Blood Gas Control (K851911) received a 510(k) decision of Substantially Equivalent on May 20, 1985, 19 days after the submission was received.
What is the product code of K851911?
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.