FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RECONDITIONED ASTRA (TM) 8
K Number: K883298
·
Decision Mar 16, 1989
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
2
Review Days
224
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Basic Information
- Device Name
- RECONDITIONED ASTRA (TM) 8
- K Number
- K883298
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Associated Electro-Medical Services, Inc.
- Date Received
- August 4, 1988
- Decision Date
- March 16, 1989
- Product Code
- JJF
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Associated Electro-Medical Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883350 | RECONDITIONED ASTRA(TM) 4 | Mar 16, 1989 | Substantially Equivalent |