510(k) K811994
K811994 is an FDA 510(k) premarket notification submitted by Endocrine-Metabolic Center for the device "RADIOIMMUNOASSAY LUTEINIZING HORMONE". The FDA issued a decision of Substantially Equivalent on Jul 27, 1981. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Endocrine-Metabolic Center has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 27, 1981
- Date Received
- Jul 14, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Luteinizing Hormone
- Device Class
- Class I
- Regulation Number
- 862.1485
- Review Panel
- CH
- Submission Type
- 510(k) Exempt