FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADIOIMMUNOASSAY TEST SYSTEM PRL
K Number: K830412
·
Decision Apr 5, 1983
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
21
Review Days
56
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Basic Information
- Device Name
- RADIOIMMUNOASSAY TEST SYSTEM PRL
- K Number
- K830412
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Monobind
- Date Received
- February 8, 1983
- Decision Date
- April 5, 1983
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFT), ordered by most recent decision date.
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Other Clearances by Monobind
| K Number | Device Name | ||
|---|---|---|---|
| K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | Aug 22, 2003 | Substantially Equivalent |
| 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 |