ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
FDA 510(k) clearance K980130 · decided 1998-02-09
Clearance details
- K-number
- K980130
- Device name
- ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
- Applicant
- Radiometer America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-14
- Decision date
- 1998-02-09
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Westlake, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic o recall (Z-1075-2014) | Radiometer America Inc | 2014-02-24 |
| Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600 recall (Z-2571-2011) | Radiometer America Inc | 2011-06-16 |
| Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from recall (Z-1386-06) | Radiometer America Inc | 2006-08-10 |
| Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, recall (Z-1323-06) | Radiometer America Inc | 2006-08-03 |
| D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer. recall (Z-1314-06) | Radiometer America Inc | 2006-08-01 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S004) | Radiometer America, Inc. | 1986-02-21 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S003) | Radiometer America, Inc. | 1985-02-22 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S002) | Radiometer America, Inc. | 1984-03-01 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S001) | Radiometer America, Inc. | 1981-09-21 |