Liquichek Blood Gas Plus Co-Oximeter Control, Models 637, 638, 639 (Radiometer)
FDA 510(k) K002536 · Bio-Rad
510(k) numberK002536
Submission
- Device name
- Liquichek Blood Gas Plus Co-Oximeter Control, Models 637, 638, 639 (Radiometer)
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- August 16, 2000
- Decision date
- August 30, 2000
- 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 |
| 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 |
|---|---|---|
| K171061 | MRSASelect IIJSO · Traditional | 12/28/2017SE |
| K122187 | Vreselect Culture MediumJSO · Traditional | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | 10/21/2011SE |
| K093678 | Platelia Aspergillus Eia Model 62793NOM · Traditional | 01/13/2011SE |
| K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensJSO · Traditional | 10/29/2010SE |
| K081362 | Platelia Lyme IgmLSR · Traditional | 06/26/2008SE |
| K081212 | Mrsaselect - Extended IncubationJSO · Traditional | 06/13/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
| K060641 | Platelia Aspergillus Eia, Model 62793NOM · Traditional | 06/02/2006SE |
Questions and answers
When was Liquichek Blood Gas Plus Co-Oximeter Control, Models 637, 638, 639 (Radiometer) cleared by the FDA?
Liquichek Blood Gas Plus Co-Oximeter Control, Models 637, 638, 639 (Radiometer) (K002536) received a 510(k) decision of Substantially Equivalent on August 30, 2000, 14 days after the submission was received.
What is the product code of K002536?
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.