FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION
K Number: K946146
·
Decision Jan 24, 1995
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
17
Review Days
39
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Basic Information
- Device Name
- CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION
- K Number
- K946146
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Clinical Controls, Inc.
- Date Received
- December 16, 1994
- Decision Date
- January 24, 1995
- 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 |
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Other Clearances by Clinical Controls, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964278 | WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 | Nov 22, 1996 | Substantially Equivalent |
| K962432 | LIQUISPEX URINE (MICRO)ALBUMIN CONTROL | Jul 5, 1996 | Substantially Equivalent |
| K955690 | AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 | Apr 24, 1996 | Substantially Equivalent |
| K955691 | SERUM VOLATILES CONTROL LEVEL 1 & 2 | Apr 24, 1996 | Substantially Equivalent |
| K946265 | FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 | Aug 24, 1995 | Substantially Equivalent |
| K935598 | PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 | May 2, 1995 | Substantially Equivalent |
| K946049 | LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 | Feb 10, 1995 | Substantially Equivalent |
| K946048 | LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 | Feb 10, 1995 | Substantially Equivalent |
| K946050 | LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 | Feb 10, 1995 | Substantially Equivalent |
| K946266 | FERRITIN CONTROL - LEVEL 1, 2, 3 | Feb 10, 1995 | Substantially Equivalent |