FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
C-PEP-RIA-100
K Number: K842267
·
Decision Sep 6, 1984
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
9
Applicant Total
2
Review Days
90
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
- C-PEP-RIA-100
- K Number
- K842267
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1135
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Institut National Des Radioelements
- Date Received
- June 8, 1984
- Decision Date
- September 6, 1984
- Product Code
- JKD
- 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 |
|---|---|---|---|
| JKD | Radioimmunoassay, C-Peptides Of Proinsulin | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JKD), ordered by most recent decision date.
AIA-PACK CPR ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE C-PEPTIDE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL C-PEPTIDE RIA (DSL #7000)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DOUBLE ANTIBODY C-PEPTIDE RIA KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
C-PEPTIDE RADIOIMMUNOASSAY TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Institut National Des Radioelements
| K Number | Device Name | ||
|---|---|---|---|
| K791128 | PTH RIA 200 | Sep 27, 1979 | Substantially Equivalent |