ABL700 Series Analyzer with Autocheck Module
FDA 510(k) K992859 · Radiometer America, Inc.
510(k) numberK992859
Submission
- Device name
- ABL700 Series Analyzer with Autocheck Module
- Applicant
- Radiometer America, Inc.
Westlake, OH, US - Received
- August 25, 1999
- Decision date
- January 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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More from Opti Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | 01/28/2016SE |
| K991417 | Abl 735 AnalyzerCHL · Traditional | 11/24/1999SE |
| K982928 | NPT7 Series Ph/Blood Gas and Co-Oximetry SystemCHL · Traditional | 01/06/1999SE |
| K980130 | ABL700 Series Blood Gas , Co-Oximetry, Electrolyte & Metabolite SystemCHL · Traditional | 02/09/1998SE |
| K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760JJS · Traditional | 01/28/1998SE |
| K974818 | ABL555 Blood Gas, Electrolyte & Metabolite SystemMMI · Traditional | 01/16/1998SE |
| K973367 | ABL555 Blood Gas, Electrolyte & Metabolite SystemCHL · Traditional | 10/06/1997SE |
| K962158 | Pico Models 30, 50, 70JKA · Traditional | 10/29/1996SE |
| K962334 | EML105 Electrolyte Metabolite AnalyzerJGS · Traditional | 10/24/1996SE |
| K961355 | MulticheckJJS · Traditional | 06/14/1996SE |
Questions and answers
When was ABL700 Series Analyzer with Autocheck Module cleared by the FDA?
ABL700 Series Analyzer with Autocheck Module (K992859) received a 510(k) decision of Substantially Equivalent on January 10, 2000, 138 days after the submission was received.
What is the product code of K992859?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.