Modification to ABL800 Flex
FDA 510(k) K050869 · Radiometer Medical Aps
510(k) numberK050869
Submission
- Device name
- Modification to ABL800 Flex
- Applicant
- Radiometer Medical Aps
Washington, DC, US - Received
- April 6, 2005
- Decision date
- August 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CIG – Diazo Colorimetry, Bilirubin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1110
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/27/2026SE |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/12/2023SE |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/20/2023SE |
| K223324 | Total Bilirubin2CIG · Traditional | Abbott Ireland Diagnostics Division | 12/29/2022SE |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP SlidesCIG · Traditional | Ortho-Clinical Diagnostics, Inc. | 04/26/2019SE |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…CIG · Traditional | Elitechgroup | 07/11/2017SE |
| K150510 | Total BilirubinCIG · Traditional | Abbott Laboratories | 04/02/2015SE |
| K131544 | Cobas C Bilirubin Total GEN.3CIG · Traditional | Roche Diagnostics | 07/17/2013SE |
| K131217 | S Test Reagent Cartridge Total BilirubinCIG · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
| K123802 | Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentCIG · Traditional | Medica Corp. | 03/01/2013SE |
More from Medica Corp.
| 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 Modification to ABL800 Flex cleared by the FDA?
Modification to ABL800 Flex (K050869) received a 510(k) decision of Substantially Equivalent on August 11, 2005, 127 days after the submission was received.
What is the product code of K050869?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.