FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IL 703, STAT SEPARATOR
K Number: K812750
·
Decision Jan 26, 1982
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
8
Applicant Total
321
Review Days
119
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Basic Information
- Device Name
- IL 703, STAT SEPARATOR
- K Number
- K812750
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Instrumentation Laboratory CO
- Date Received
- September 29, 1981
- Decision Date
- January 26, 1982
- Product Code
- JRL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JRL | Unit, Filter, Membrane | FDA class 1 | Clinical Chemistry |
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