Luteinizing Hormone Radioimmunoassay Sys
FDA 510(k) K800106 · Radioimmunoassay, Inc.
510(k) numberK800106
Submission
- Device name
- Luteinizing Hormone Radioimmunoassay Sys
- Applicant
- Radioimmunoassay, Inc.
Mchenry, IL, US - Received
- January 16, 1980
- Decision date
- February 13, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEP – Radioimmunoassay, Luteinizing Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1485
- Specialty
- Clinical Chemistry
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|---|---|---|
| K802135 | Testosterone Radioimmunoassy KitCDZ · Traditional | 10/10/1980SE |
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| K792539 | Triiodothyronine Ria SystemCDP · Traditional | 01/16/1980SE |
| K792154 | Thyroid Stimulating HormoneJLW · Traditional | 11/13/1979SE |
| K792153 | Digoxin Radioimmunoassay SystemDPB · Traditional | 11/13/1979SE |
| K792036 | Cortisol Radioimmunoassay SystemCGR · Traditional | 10/30/1979SE |
| K780672 | 125 I-T4 Ria ReagentCDX · Traditional | 06/06/1978SE |
| K780671 | 125 I-T3 Uptake ReagentCEE · Traditional | 06/06/1978SE |
Questions and answers
When was Luteinizing Hormone Radioimmunoassay Sys cleared by the FDA?
Luteinizing Hormone Radioimmunoassay Sys (K800106) received a 510(k) decision of Substantially Equivalent on February 13, 1980, 28 days after the submission was received.
What is the product code of K800106?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.