FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LH/FSH RADIOIMMUNOASSAY KIT
K Number: K853837
·
Decision Oct 16, 1985
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
9
Review Days
30
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Basic Information
- Device Name
- LH/FSH RADIOIMMUNOASSAY KIT
- K Number
- K853837
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bioclinical Group
- Date Received
- September 16, 1985
- Decision Date
- October 16, 1985
- Product Code
- CEP
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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Other Clearances by Bioclinical Group
| K Number | Device Name | ||
|---|---|---|---|
| K862968 | FREE T3 RADIOIMMUNOASSAY KIT | Sep 25, 1986 | Substantially Equivalent |
| K832638 | CORTISOL RADIOIMMUNOASSAY KIT | Sep 12, 1983 | Substantially Equivalent |
| K823005 | BIO MAG FREE T4 RADIOIMMUNOASSAY KIT | Dec 15, 1982 | Substantially Equivalent |
| K823004 | BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT | Nov 5, 1982 | Substantially Equivalent |
| K822840 | RADIOIMMUNOASSAY, HUMAN CHORRIONIC | Oct 27, 1982 | Substantially Equivalent |
| K822515 | B-HCG RADIOIMMUNOASSAY KIT | Sep 14, 1982 | Substantially Equivalent |
| K821241 | FREE T4 RADIOIMMUNOASSAY KIT | Jun 1, 1982 | Substantially Equivalent |
| K821101 | TOTAL RADIOIMMUNOASSAY KIT | May 5, 1982 | Substantially Equivalent |