FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL PROTEIN
K Number: K875222
·
Decision Jan 22, 1988
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
41
Review Days
31
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Basic Information
- Device Name
- TOTAL PROTEIN
- K Number
- K875222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Catachem, Inc.
- Date Received
- December 22, 1987
- Decision Date
- January 22, 1988
- 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
FDA 510(k)
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TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
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FDA Class 2
·Clinical Chemistry
CARESIDE TOTAL PROTEIN
FDA 510(k)
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·Clinical Chemistry
TOTAL PROTEIN OR TP
FDA 510(k)
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·Clinical Chemistry
CSF/URINE TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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|---|---|---|---|
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| K932871 | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | Sep 8, 1993 | Substantially Equivalent |
| K903341 | MAGNESIUM | Aug 22, 1990 | Substantially Equivalent |
| K902326 | AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS | Jul 31, 1990 | Substantially Equivalent |
| K902877 | TOTAL IRON FOR MANUAL/AUTOMATED | Jul 27, 1990 | Substantially Equivalent |
| K895748 | BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS | Dec 21, 1989 | Substantially Equivalent |
| K895821 | URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS | Dec 5, 1989 | Substantially Equivalent |
| K894715 | CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS | Nov 8, 1989 | Substantially Equivalent |
| K894389 | CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS | Oct 12, 1989 | Substantially Equivalent |