Quantimune HLH Ria
FDA 510(k) K821346 · Bio-Rad
510(k) numberK821346
Submission
- Device name
- Quantimune HLH Ria
- Applicant
- Bio-Rad
Mchenry, IL, US - Received
- May 5, 1982
- Decision date
- May 28, 1982
- 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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| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
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Questions and answers
When was Quantimune HLH Ria cleared by the FDA?
Quantimune HLH Ria (K821346) received a 510(k) decision of Substantially Equivalent on May 28, 1982, 23 days after the submission was received.
What is the product code of K821346?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.