FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVL OPTI CRITICAL CARE ANALYZER
K Number: K984299
·
Decision Dec 11, 1998
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
28
Applicant Total
33
Review Days
10
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Basic Information
- Device Name
- AVL OPTI CRITICAL CARE ANALYZER
- K Number
- K984299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avl Scientific Corp.
- Date Received
- December 1, 1998
- Decision Date
- December 11, 1998
- Product Code
- JFP
- 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 |
|---|---|---|---|
| JFP | Electrode, Ion Specific, Calcium | FDA class 2 | Clinical Chemistry |
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Other Clearances by Avl Scientific Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K001632 | OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 | Jun 19, 2000 | Substantially Equivalent |
| K000103 | AVL OPTI R ANALYZER | Mar 20, 2000 | Substantially Equivalent |
| K993837 | AVL OPTI CRITICAL CARE ANALYZER | Dec 16, 1999 | Substantially Equivalent |
| K990092 | AVL OMNI MODULAR ANALYZER | Jan 29, 1999 | Substantially Equivalent |
| K974784 | AVL OPTI CRITICAL CARE ANALYZER | Feb 24, 1998 | Substantially Equivalent |
| K974822 | AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL | Jan 22, 1998 | Substantially Equivalent |
| K972733 | AVL OMNI ANALYZER | Sep 9, 1997 | Substantially Equivalent |
| K972673 | AVL 9181 ELECTROLYTE ANALYZER | Aug 20, 1997 | Substantially Equivalent |
| K963964 | AVL COMPACT 3 PH/BLOOD GAS ANALYZER | Nov 29, 1996 | Substantially Equivalent |
| K961458 | AVL 9180 ELECTROLYTE ANALYZER | Jun 12, 1996 | Substantially Equivalent |