FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
K Number: K030860
·
Decision Aug 22, 2003
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
85
Applicant Total
21
Review Days
157
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Basic Information
- Device Name
- ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
- K Number
- K030860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Monobind
- Date Received
- March 18, 2003
- Decision Date
- August 22, 2003
- Product Code
- KLI
- 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 |
|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | FDA class 2 | Clinical Chemistry |
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Other Clearances by Monobind
| K Number | Device Name | ||
|---|---|---|---|
| K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | Apr 5, 2002 | Substantially Equivalent |
| K980088 | T-UPTAKE MICROPLATE EIA | Feb 4, 1998 | Substantially Equivalent |
| K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) | Sep 2, 1997 | Substantially Equivalent |
| K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | Jul 3, 1997 | Substantially Equivalent |
| K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA | Jul 3, 1997 | Substantially Equivalent |
| K971780 | THYROTROPIN(TSH) ELISA | Jun 24, 1997 | Substantially Equivalent |
| K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA | Jun 24, 1997 | Substantially Equivalent |
| K971779 | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | Jun 16, 1997 | Substantially Equivalent |
| K971709 | TOTAL THROXINE MICROPLATE EIA(225-300) | Jun 16, 1997 | Substantially Equivalent |
| K926345 | TRIODOTHYRONINE (TC) COATED TUBE RIA | Feb 25, 1993 | Substantially Equivalent |