FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
K Number: K001607
·
Decision Oct 5, 2000
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
3
Review Days
134
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Basic Information
- Device Name
- REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
- K Number
- K001607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Repromedix Corp.
- Date Received
- May 24, 2000
- Decision Date
- October 5, 2000
- Product Code
- CDP
- 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | FDA class 2 | Clinical Chemistry |
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