FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AALTO LDH ISOENZYME CONTROL SERUM
K Number: K820360
·
Decision Mar 4, 1982
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
35
Review Days
23
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Basic Information
- Device Name
- AALTO LDH ISOENZYME CONTROL SERUM
- K Number
- K820360
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Aalto Scientific, Ltd.
- Date Received
- February 9, 1982
- Decision Date
- March 4, 1982
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJT), ordered by most recent decision date.
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LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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