FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISO-SEP SYSTEM
K Number: K842018
·
Decision Sep 28, 1984
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
7
Applicant Total
5
Review Days
133
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Basic Information
- Device Name
- ISO-SEP SYSTEM
- K Number
- K842018
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1445
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Berwick Medical Products, Inc.
- Date Received
- May 18, 1984
- Decision Date
- September 28, 1984
- Product Code
- CEX
- 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 |
|---|---|---|---|
| CEX | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | FDA class 2 | Clinical Chemistry |
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