FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIA SYS. FOR HUMAN GROWTH HORMONE
K Number: K780347
·
Decision Apr 12, 1978
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
35
Applicant Total
41
Review Days
41
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
- RIA SYS. FOR HUMAN GROWTH HORMONE
- K Number
- K780347
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1370
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem-Behring Corp.
- Date Received
- March 2, 1978
- Decision Date
- April 12, 1978
- Product Code
- CFL
- 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 |
|---|---|---|---|
| CFL | Radioimmunoassay, Human Growth Hormone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFL), ordered by most recent decision date.
SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL 9100 IGF-II IRMA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HUMAN GROWTH HORMONE IMMUNOASSAY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL ACTIVE NON-EXTRACTION IGF-I IRMA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Calbiochem-Behring Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K831811 | REVOLUTION RADIAL IMMUNODIFFUSION PLATE | Jul 28, 1983 | Substantially Equivalent |
| K831036 | ENA TEST KIT SM & RNP AUTO ANTIBODY | Apr 27, 1983 | Substantially Equivalent |
| K830214 | AFT SYSTEM III | Mar 9, 1983 | Substantially Equivalent |
| K820812 | CREATINE KINASE-MB KIT | Apr 12, 1982 | Substantially Equivalent |
| K813493 | ENZYGNOST TM RUBELLA IGM | Mar 4, 1982 | Substantially Equivalent |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | Jan 26, 1982 | Substantially Equivalent |
| K812458 | PADAC | Sep 23, 1981 | Substantially Equivalent |
| K810718 | C-PEPTICE REAGENTS | Mar 31, 1981 | Substantially Equivalent |
| K810669 | PANTRAK E.K. | Mar 31, 1981 | Substantially Equivalent |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | Mar 11, 1981 | Substantially Equivalent |