FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD
K Number: K844710
·
Decision Jan 7, 1985
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
33
Applicant Total
9
Review Days
35
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Basic Information
- Device Name
- EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD
- K Number
- K844710
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Logos Scientific, Inc.
- Date Received
- December 3, 1984
- Decision Date
- January 7, 1985
- Product Code
- JJN
- 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 |
|---|---|---|---|
| JJN | Apparatus, Electrophoresis, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Logos Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902614 | ELVI 828 DIGICLOT MULTISCAN | Nov 8, 1990 | Substantially Equivalent |
| K843375 | ELVI 655 FLAME PHOTOMETER | May 20, 1985 | Substantially Equivalent |
| K843296 | ELVI 675 DIGITRON | Sep 13, 1984 | Substantially Equivalent |
| K842313 | ELVI 146 SEROSCAN | Sep 10, 1984 | Substantially Equivalent |
| K842056 | ELVI 165 PROTEO SEROSKOP | Jun 22, 1984 | Substantially Equivalent |
| K841804 | ELVI 70 SAFETY CHAMBER | May 31, 1984 | Substantially Equivalent |
| K840757 | ELVI 444 BILITRON | May 30, 1984 | Substantially Equivalent |
| K841288 | ELVI 18 | May 2, 1984 | Substantially Equivalent |