FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIASET PROLACTIN RIA KIT
K Number: K823304
·
Decision Dec 22, 1982
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
15
Review Days
47
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Basic Information
- Device Name
- RIASET PROLACTIN RIA KIT
- K Number
- K823304
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immulok, Inc.
- Date Received
- November 5, 1982
- Decision Date
- December 22, 1982
- 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 |
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|---|---|---|---|
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| K823055 | FLOUROSET IMMUNOFLUORESCENT ANTIBODY | Nov 5, 1982 | Substantially Equivalent |
| K822606 | CYTOMEGALOVIRUS ANTOBODY IGG | Nov 1, 1982 | Substantially Equivalent |
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| K822607 | ANTINUCLEAR ANTOBODY CELL SUBSTRATE | Sep 17, 1982 | Substantially Equivalent |
| K821567 | IMMULOK CULTURESET | Jun 25, 1982 | Substantially Equivalent |
| K821411 | HISTOSET IMMUNOPEROFIDASE TISSUE | Jun 25, 1982 | Substantially Equivalent |