FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
125-I FSH RADIOIMMUNOASSAY KIT
K Number: K823379
·
Decision Dec 22, 1982
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
9
Review Days
40
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Basic Information
- Device Name
- 125-I FSH RADIOIMMUNOASSAY KIT
- K Number
- K823379
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clinetics Corp.
- Date Received
- November 12, 1982
- Decision Date
- December 22, 1982
- Product Code
- CGJ
- 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 |
|---|---|---|---|
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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Other Clearances by Clinetics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862180 | MODIFIED COTROPIN RADIOIMMUNOASSAY KIT | Jul 7, 1986 | Substantially Equivalent |
| K844066 | COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH | Jan 18, 1985 | Substantially Equivalent |
| K841580 | TSH RECEPTOR ANTIBODY KIT 125I TSH | Oct 22, 1984 | Substantially Equivalent |
| K833934 | ADRENOCORTICOTROPIC HORMONE TEST | Apr 4, 1984 | Substantially Equivalent |
| K830357 | RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E | Mar 17, 1983 | Substantially Equivalent |
| K823380 | 125-I LH RADIOIMMUNOASSAY KIT | Dec 22, 1982 | Substantially Equivalent |
| K822152 | HCG BETA RIA KIT | Sep 2, 1982 | Substantially Equivalent |
| K801306 | CLINETICS PCA COLUMN | Sep 26, 1980 | Substantially Equivalent |