FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
K Number: K050125
·
Decision Mar 18, 2005
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
16
Review Days
58
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
- RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
- K Number
- K050125
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- More Diagnostics
- Date Received
- January 19, 2005
- Decision Date
- March 18, 2005
- Product Code
- JJY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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
Other Clearances by More Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K072257 | MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL | Jan 30, 2008 | Substantially Equivalent |
| K982845 | CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 | Aug 21, 1998 | Substantially Equivalent |
| K980331 | IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S | Mar 16, 1998 | Substantially Equivalent |
| K972976 | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL | Aug 29, 1997 | Substantially Equivalent |
| K970778 | LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 | Apr 17, 1997 | Substantially Equivalent |
| K946193 | FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 | Aug 24, 1995 | Substantially Equivalent |
| K943571 | MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS | Jun 15, 1995 | Substantially Equivalent |
| K944999 | SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 | Jun 6, 1995 | Substantially Equivalent |
| K941876 | WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 | Jul 28, 1994 | Substantially Equivalent |
| K941698 | SERUM VOLATILES CONTROL - LEVELS 1 AND 2 | Jul 28, 1994 | Substantially Equivalent |