FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIA THYROID STIMULATING HORMONE ELISA KIT
K Number: K930050
·
Decision Aug 19, 1993
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
231
Review Days
226
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Basic Information
- Device Name
- SIA THYROID STIMULATING HORMONE ELISA KIT
- K Number
- K930050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sigma Chemical Co.
- Date Received
- January 5, 1993
- Decision Date
- August 19, 1993
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K933692 | SIGMA CO2 ACID REAGENT | Dec 9, 1993 | Substantially Equivalent |
| K933695 | SIGMA ELECTROLYTE BUFFER | Oct 22, 1993 | Substantially Equivalent |
| K933697 | SIGMA CRE REAGENT | Oct 18, 1993 | Substantially Equivalent |
| K933693 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 | Oct 13, 1993 | Substantially Equivalent |