FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K Number: K974818
·
Decision Jan 16, 1998
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
94
Applicant Total
50
Review Days
24
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Basic Information
- Device Name
- ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
- K Number
- K974818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiometer America, Inc.
- Date Received
- December 23, 1997
- Decision Date
- January 16, 1998
- Product Code
- MMI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K982928 | NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM | Jan 6, 1999 | Substantially Equivalent |
| K980130 | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM | Feb 9, 1998 | Substantially Equivalent |
| K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | Jan 28, 1998 | Substantially Equivalent |
| K973367 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | Oct 6, 1997 | Substantially Equivalent |
| K962158 | PICO MODELS 30, 50, 70 | Oct 29, 1996 | Substantially Equivalent |
| K962334 | EML105 ELECTROLYTE METABOLITE ANALYZER | Oct 24, 1996 | Substantially Equivalent |
| K961355 | MULTICHECK | Jun 14, 1996 | Substantially Equivalent |