AUTOCHECK6+
FDA 510(k) K051928 · Radiometer Medical Aps
510(k) numberK051928
Submission
- Device name
- AUTOCHECK6+
- Applicant
- Radiometer Medical Aps
Bronshoj, DK - Received
- July 18, 2005
- Decision date
- October 12, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| 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 AUTOCHECK6+ cleared by the FDA?
AUTOCHECK6+ (K051928) received a 510(k) decision of Substantially Equivalent on October 12, 2005, 86 days after the submission was received.
What is the product code of K051928?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.