ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set— 510(k) K143075
Substantially EquivalentTosoh Bioscience, Inc.
FDA 510(k) clearance K143075 for ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set, Substantially Equivalent on 2015-07-02. Applicant: Tosoh Bioscience, Inc.. Device class: 1.
Clearance details
- Applicant
- Tosoh Bioscience, Inc.
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Franciso, CA, US
Recent devices under product code CDZ
view allMore clearances from Tosoh Bioscience, Inc.
view allRecalls naming K143075
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 K143075.
Data sourced from openFDA. This site is unofficial and independent of the FDA.