FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROLACTIN SYSTEM BY RIA
K Number: K851330
·
Decision Apr 29, 1985
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
4
Review Days
25
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
- PROLACTIN SYSTEM BY RIA
- K Number
- K851330
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- American Bioclinical, Inc.
- Date Received
- April 4, 1985
- Decision Date
- April 29, 1985
- Product Code
- CFT
- 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 |
|---|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFT), ordered by most recent decision date.
PROLACTIN (PRL) HORMONE MICROPLATE ELISA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SEALITE SCIENCES, INC. AQUALITE PROLACTIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS PROLACTIN ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL ACTIVE PROLACTIN IRMA
FDA 510(k)
FDA Class 1
·Clinical Chemistry