PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM— 510(k) K952075
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K952075 for PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM, Substantially Equivalent on 1995-06-13. Applicant: Bayer Corp.. Device class: 1.
Clearance details
- Applicant
- Bayer Corp.
- Product code
- Code JLS
- Device class
- Class 1
- Regulation
- 21 CFR 862.1620
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.