FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORALENT COAT 125I CORTISOL RADIOIMM.
K Number: K791835
·
Decision Sep 27, 1979
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
83
Applicant Total
15
Review Days
10
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
- CORALENT COAT 125I CORTISOL RADIOIMM.
- K Number
- K791835
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Radioassay Systems Laboratories, Inc.
- Date Received
- September 17, 1979
- Decision Date
- September 27, 1979
- Product Code
- CGR
- 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 |
|---|---|---|---|
| CGR | Radioimmunoassay, Cortisol | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGR), ordered by most recent decision date.
Access Cortisol; DxC 500i Clinical Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IDS Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMMULITE/IMMULITE® 1000 Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMMULITE® 2000 Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CORTISOL ELISA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Radioassay Systems Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862204 | RSL (125I) ALDOSTERONE KIT | Sep 25, 1986 | Substantially Equivalent |
| K842960 | ANDROSTENEDIONE BY RIA | Sep 27, 1984 | Substantially Equivalent |
| K840886 | HYDROXYPROGESTERONE BY RIA 17A | Apr 18, 1984 | Substantially Equivalent |
| K831855 | HATCH KIT | Jul 28, 1983 | Substantially Equivalent |
| K802195 | DEHYDROEPIANDROSTERONE SULFATE KIT RIA | Oct 23, 1980 | Substantially Equivalent |
| K800126 | RSL (125 L) PROGESTERONE KIT | Feb 13, 1980 | Substantially Equivalent |
| K791999 | (125I) TESTOSTERONE KIT | Oct 30, 1979 | Substantially Equivalent |
| K791651 | TOTAL ESTROGENS KIT BY RIA | Sep 27, 1979 | Substantially Equivalent |
| K791728 | RSL'S ASSAY PROCEDURE QUANTITATION | Sep 27, 1979 | Substantially Equivalent |
| K791740 | SERUM 11-DESOXYCORTISOL I AS TRACER | Sep 27, 1979 | Substantially Equivalent |