FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS
K Number: K800106
·
Decision Feb 13, 1980
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
9
Review Days
28
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Basic Information
- Device Name
- LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS
- K Number
- K800106
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Radioimmunoassay, Inc.
- Date Received
- January 16, 1980
- Decision Date
- February 13, 1980
- 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 Radioimmunoassay, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802135 | TESTOSTERONE RADIOIMMUNOASSY KIT | Oct 10, 1980 | Substantially Equivalent |
| K800107 | FOLLICLE STIMULATING HORMONE | Feb 13, 1980 | Substantially Equivalent |
| K792539 | TRIIODOTHYRONINE RIA SYSTEM | Jan 16, 1980 | Substantially Equivalent |
| K792153 | DIGOXIN RADIOIMMUNOASSAY SYSTEM | Nov 13, 1979 | Substantially Equivalent |
| K792154 | THYROID STIMULATING HORMONE | Nov 13, 1979 | Substantially Equivalent |
| K792036 | CORTISOL RADIOIMMUNOASSAY SYSTEM | Oct 30, 1979 | Substantially Equivalent |
| K780671 | 125 I-T3 UPTAKE REAGENT | Jun 6, 1978 | Substantially Equivalent |
| K780672 | 125 I-T4 RIA REAGENT | Jun 6, 1978 | Substantially Equivalent |