ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
FDA 510(k) clearance K974818 · decided 1998-01-16
Clearance details
- K-number
- K974818
- Device name
- ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
- Applicant
- Radiometer America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-23
- Decision date
- 1998-01-16
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- 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 |
|---|---|---|
| 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 |
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 |