FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS
K Number: K960378
·
Decision Apr 3, 1996
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
3
Review Days
68
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS
- K Number
- K960378
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Actimed Laboratories, Inc.
- Date Received
- January 26, 1996
- Decision Date
- April 3, 1996
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJX), ordered by most recent decision date.
Beta-CrossLaps CalCheck 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Elecsys CYFRA 21-1 CalCheck 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Multichem A1c
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Audit MicroControls Linearity DROP LQ Blood Glucose
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON CMV IgM Serum Control Set
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON EBV IgM Serum Control Set
FDA 510(k)
FDA Class 1
·Clinical Chemistry