FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URINE/CSF MICROPROTEIN REAGENT
K Number: K913225
·
Decision Oct 11, 1991
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
21
Review Days
84
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Basic Information
- Device Name
- URINE/CSF MICROPROTEIN REAGENT
- K Number
- K913225
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intersect Systems, Inc.
- Date Received
- July 19, 1991
- Decision Date
- October 11, 1991
- 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)
FDA Class 2
·Clinical Chemistry
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARESIDE TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL PROTEIN OR TP
FDA 510(k)
FDA Class 2
·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
Other Clearances by Intersect Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021636 | ALBUMIN REAGENT | Jul 17, 2002 | Substantially Equivalent |
| K011972 | DIRECT BILIRUBIN REAGENT | Aug 27, 2001 | Substantially Equivalent |
| K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | Jul 25, 2001 | Substantially Equivalent |
| K003892 | TOTAL BILIRUBIN REAGENT | Feb 20, 2001 | Substantially Equivalent |
| K983937 | DUAL VIAL CREATININE REAGENT | Jan 6, 1999 | Substantially Equivalent |
| K974833 | CK-NAC REAGENT | Feb 13, 1998 | Substantially Equivalent |
| K941807 | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT | Sep 14, 1994 | Substantially Equivalent |
| K932888 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT | Jan 31, 1994 | Substantially Equivalent |
| K934039 | INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET | Nov 16, 1993 | Substantially Equivalent |
| K932267 | ENZYMATIC CO2 REAGENT, MODIFICATION | Sep 24, 1993 | Substantially Equivalent |