FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
K Number: K972976
·
Decision Aug 29, 1997
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
16
Review Days
18
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Basic Information
- Device Name
- CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
- K Number
- K972976
- 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
- August 11, 1997
- Decision Date
- August 29, 1997
- 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
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ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
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LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
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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
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 |
| K050125 | RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 | Mar 18, 2005 | 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 |
| 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 |