FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LDH ISOENZYME CONTROL
K Number: K771894
·
Decision Dec 22, 1977
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
7
Applicant Total
4
Review Days
77
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Basic Information
- Device Name
- LDH ISOENZYME CONTROL
- K Number
- K771894
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1445
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Reagents & Diagnostics, Inc.
- Date Received
- October 6, 1977
- Decision Date
- December 22, 1977
- 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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