FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
K Number: K935598
·
Decision May 2, 1995
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
17
Review Days
529
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Basic Information
- Device Name
- PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
- K Number
- K935598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7340
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Clinical Controls, Inc.
- Date Received
- November 19, 1993
- Decision Date
- May 2, 1995
- Product Code
- GIL
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GIL | Plasma, Fibrinogen Control | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GIL), ordered by most recent decision date.
N/T PROTEIN CONTROL PY
FDA 510(k)
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·Hematology
FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3
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·Hematology
FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
FDA 510(k)
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N/T PROTEIN CONTROL PY
FDA 510(k)
FDA Class 2
·Hematology
LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2
FDA 510(k)
FDA Class 2
·Hematology
FIBRINOGEN CONTROL
FDA 510(k)
FDA Class 2
·Hematology
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 |
| 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 |
| K946144 | LIQUISPEX(TM) URINE ETHANOL CONTROL | Feb 8, 1995 | Substantially Equivalent |