FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET
K Number: K893140
·
Decision Jun 23, 1989
Classifications
1
FEI Numbers
280
Registration Numbers
280
Same Product Code
492
Applicant Total
38
Review Days
59
Basic Information
- Device Name
- DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET
- K Number
- K893140
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- CASCO STANDARDS
- Date Received
- April 25, 1989
- Decision Date
- June 23, 1989
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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