Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3
FDA 510(k) K130236 · Radiometer Medical Aps
510(k) numberK130236
Submission
- Device name
- Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3
- Applicant
- Radiometer Medical Aps
Bronshoj, DK - Received
- January 30, 2013
- Decision date
- March 15, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K002865 | Liquichek Blood Gas Plus E Control, Model 576, 577, 578JJS · Traditional | Bio-Rad | 09/25/2000SE |
More from Bio-Rad
| 510(k) | Device | Decision |
|---|---|---|
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXJHX · Traditional | 09/21/2017SE |
| K170882 | ABL90 Flex, ABL90 Flex PlusMQM · Traditional | 04/28/2017SE |
| K160153 | ABL90 Flex PlusCHL · Special | 11/04/2016SE |
| K142898 | ABL800 FLEX with AQURE connectivityCHL · Special | 06/17/2015SE |
| K150226 | Hematocrit and Metabolite QUALICHECKJJS · Traditional | 05/13/2015SE |
| K132691 | ABL90 FlexMQM · Traditional | 11/13/2014SE |
| K131988 | ABL90 Flex AnalyzerCHL · Traditional | 09/17/2013SE |
| K130144 | ABL90 FlexCHL · Special | 07/31/2013SE |
| K123748 | ABL90 FlexCHL · Special | 05/07/2013SE |
| K130415 | High Metabolite QualicheckJJS · Traditional | 03/26/2013SE |
Questions and answers
When was Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3 cleared by the FDA?
Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3 (K130236) received a 510(k) decision of Substantially Equivalent on March 15, 2013, 44 days after the submission was received.
What is the product code of K130236?
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.