AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
FDA 510(k) clearance K872196 · decided 1987-07-31
Clearance details
- K-number
- K872196
- Device name
- AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
- Applicant
- American Dade
- Decision
- Substantially Equivalent
- Date received
- 1987-06-08
- Decision date
- 1987-07-31
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- JJS
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
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| RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 (K130236) | Radiometer Medical Aps | 2013-03-15 |
| MISSION CONTROLS (K033063) | Diamond Diagnostics, Inc. | 2003-12-12 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 (K022529) | Bio-Rad | 2002-08-15 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 (K022525) | Bio-Rad | 2002-08-15 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (K003242) | Bio-Rad | 2000-11-30 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (K003239) | Bio-Rad | 2000-11-30 |
| LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 (K002865) | Bio-Rad | 2000-09-25 |
| LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 (K002866) | Bio-Rad | 2000-09-25 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) (K002536) | Bio-Rad | 2000-08-30 |
Recalls involving this device
No recalls on record reference this clearance.