JJS — Controls For Blood-Gases, (Assayed And Unassayed) Class I
FDA product code JJS covers "Controls For Blood-Gases, (Assayed And Unassayed)", a Class I medical device regulated under 21 CFR 862.1660. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JJS
- Device Class
- Class I
- Regulation Number
- 862.1660
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K152553 | eurotrol | CueSee Hypoxic | April 22, 2016 |
| K150226 | radiometer medical aps | Hematocrit and Metabolite QUALICHECK | May 13, 2015 |
| K130415 | radiometer medical aps | HIGH METABOLITE QUALICHECK | March 26, 2013 |
| K130236 | radiometer medical aps | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL | March 15, 2013 |
| K033063 | diamond diagnostics | MISSION CONTROLS | December 12, 2003 |
| K022529 | bio-rad | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, A | August 15, 2002 |
| K022525 | bio-rad | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 | August 15, 2002 |
| K003239 | bio-rad | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 | November 30, 2000 |
| K003242 | bio-rad | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 | November 30, 2000 |
| K002866 | bio-rad | LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 | September 25, 2000 |
| K002865 | bio-rad | LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 | September 25, 2000 |
| K002535 | bio-rad | LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 | August 30, 2000 |
| K002536 | bio-rad | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) | August 30, 2000 |
| K002120 | bio-rad | LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 | August 21, 2000 |
| K980135 | radiometer america | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | January 28, 1998 |
| K972861 | instrumentation laboratory | IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) | August 19, 1997 |
| K961355 | radiometer america | MULTICHECK | June 14, 1996 |
| K961354 | radiometer america | QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) | June 14, 1996 |
| K961441 | instrumentarium | TONOMETERED SLAINE BLOOD GAS CONTROL | April 30, 1996 |
| K955340 | direct solutions | EUROTROL GAS - ISE CONTROL | December 26, 1995 |