FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HUMAN FOLLICLE STIMULATING HORMONE
K Number: K780016
·
Decision Feb 3, 1978
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
29
Review Days
31
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Basic Information
- Device Name
- HUMAN FOLLICLE STIMULATING HORMONE
- K Number
- K780016
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pcl-Ria, Inc.
- Date Received
- January 3, 1978
- Decision Date
- February 3, 1978
- Product Code
- CGI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| CGI | Radioimmunoassay, Estriol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGI), ordered by most recent decision date.
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
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ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
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ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
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COAT-A-COUNT FREE ESTRIOL
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AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
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FDA Class 1
·Clinical Chemistry
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Pcl-Ria, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830526 | B-GCG SYSTEM BY RIA | Apr 5, 1983 | Substantially Equivalent |
| K822935 | THYROID STIMULATING HORMONE | Nov 1, 1982 | Substantially Equivalent |
| K823014 | DIGOXIN KIT | Nov 1, 1982 | Substantially Equivalent |
| K822612 | T3 UPTAKE KITS | Sep 30, 1982 | Substantially Equivalent |
| K820886 | THYROXINE T4 KIT | Apr 16, 1982 | Substantially Equivalent |
| K820358 | FOLLICLE STIMULATING HORMONE KIT | Mar 26, 1982 | Substantially Equivalent |
| K820357 | LUTEINIZING HORMONE KIT | Mar 25, 1982 | Substantially Equivalent |
| K812666 | THYROXINE (T4) 125I | Oct 2, 1981 | Substantially Equivalent |
| K810867 | FOLLICLE STIMULATING HORMONE (FSH) | Apr 14, 1981 | Substantially Equivalent |
| K810852 | FOLLICLE STIMULATING HORMONE ANTISERUM | Apr 8, 1981 | Substantially Equivalent |