FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIROTROL III
K Number: K974613
·
Decision Jan 27, 1998
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
4
Review Days
47
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
- VIROTROL III
- K Number
- K974613
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Blackhawk Biosystems, Inc.
- Date Received
- December 11, 1997
- Decision Date
- January 27, 1998
- Product Code
- JJY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJY), ordered by most recent decision date.
Multichem IA Plus
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Audit MicroControls Linearity FD Tumor Markers II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Liquichek Cardiac Markers Plus Control LT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
FDA 510(k)
FDA Class 1
·Clinical Chemistry