FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
K Number: K011128
·
Decision Sep 6, 2001
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
15
Applicant Total
68
Review Days
146
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
- NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
- K Number
- K011128
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1085
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nichols Institute Diagnostics
- Date Received
- April 13, 2001
- Decision Date
- September 6, 2001
- Product Code
- CIB
- 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 |
|---|---|---|---|
| CIB | Radioimmunoassay, Angiotensin I And Renin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CIB), ordered by most recent decision date.
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CISBIO RENIN RIA TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVE RENIN IRMA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BUHLMANN ANGIOSTENSIN II RIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Nichols Institute Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K050784 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Jun 1, 2005 | Substantially Equivalent |
| K042676 | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY | Dec 17, 2004 | Substantially Equivalent |
| K042689 | NICHOLS ADVANTAGE CORTISOL | Dec 9, 2004 | Substantially Equivalent |
| K040813 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 | Jun 8, 2004 | Substantially Equivalent |
| K033727 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY | Apr 22, 2004 | Substantially Equivalent |
| K033302 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 | Jan 26, 2004 | Substantially Equivalent |
| K032188 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Jul 31, 2003 | Substantially Equivalent |
| K022356 | NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY | Oct 25, 2002 | Substantially Equivalent |
| K022472 | PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) | Oct 9, 2002 | Substantially Equivalent |
| K013992 | NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY | Dec 13, 2001 | Substantially Equivalent |