Access(R) Human Luteinzing Hormone Assay
FDA 510(k) K940549 · Bio-Rad Laboratories, Inc.
510(k) numberK940549
Submission
- Device name
- Access(R) Human Luteinzing Hormone Assay
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- February 7, 1994
- Decision date
- April 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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Questions and answers
When was Access(R) Human Luteinzing Hormone Assay cleared by the FDA?
Access(R) Human Luteinzing Hormone Assay (K940549) received a 510(k) decision of Substantially Equivalent on April 6, 1994, 58 days after the submission was received.
What is the product code of K940549?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.