FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COULTER TOTAL PROTEIN REAGENT
K Number: K897166
·
Decision Feb 23, 1990
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
101
Review Days
57
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Basic Information
- Device Name
- COULTER TOTAL PROTEIN REAGENT
- K Number
- K897166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Coulter Electronics, Inc.
- Date Received
- December 28, 1989
- Decision Date
- February 23, 1990
- Product Code
- CEK
- 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 |
|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEK), ordered by most recent decision date.
HICHEM TOTAL PROTEIN REAGENT
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TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
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CARESIDE TOTAL PROTEIN
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TOTAL PROTEIN OR TP
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CSF/URINE TOTAL PROTEIN
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STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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| K923530 | COULTER MULTI-Q-PREP | Oct 14, 1992 | Substantially Equivalent |
| K922181 | COULTER MH009 | Aug 17, 1992 | Substantially Equivalent |
| K922704 | COULTER MAXM W/ AUTOLOADER | Jul 27, 1992 | Substantially Equivalent |
| K921567 | COULTER MH017 | Jul 6, 1992 | Substantially Equivalent |
| K912133 | PX COULTER(R) CELL CONTROL | Jul 17, 1991 | Substantially Equivalent |
| K911385 | COULTER(R) MH010 | Jun 17, 1991 | Substantially Equivalent |
| K905771 | COULTER DART AST (GOT) REAGENT | Feb 26, 1991 | Substantially Equivalent |