FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAT KIT, MICROPROTEIN
K Number: K781897
·
Decision Jan 10, 1979
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
10
Review Days
58
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STAT KIT, MICROPROTEIN
- K Number
- K781897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pierce Chemical Co.
- Date Received
- November 13, 1978
- Decision Date
- January 10, 1979
- 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 Pierce Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K895661 | GLYCOTEST II GLYHB ASSAY KIT | Dec 7, 1989 | Substantially Equivalent |
| K831837 | CLINOVATIVE II DIAGNOSTIC KIT | Aug 1, 1983 | Substantially Equivalent |
| K821360 | GLYCO-GEL TEST KIT | Jun 2, 1982 | Substantially Equivalent |
| K820279 | GLYCO-GEL TEST KIT | Apr 8, 1982 | Substantially Equivalent |
| K780827 | URIC ACID RAPID STAT KIT | Jun 13, 1978 | Substantially Equivalent |
| K780826 | BILIRUBIN RAPID STAT KIT | May 26, 1978 | Substantially Equivalent |
| K780825 | TRIGLYCERIDE C-37 RAPID STAT KIT | May 26, 1978 | Substantially Equivalent |
| K780512 | AUTO/STAT KIT | May 3, 1978 | Substantially Equivalent |
| K780331 | CHOLESTEROL RAPID SLAT KIT HDL | Apr 6, 1978 | Substantially Equivalent |