ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY— 510(k) K940549
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K940549 for ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY, Substantially Equivalent on 1994-04-06. Applicant: Bio-Rad Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code CEP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code CEP
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K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K940549.
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