BAYER PSA ASSAY— 510(k) K994221
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K994221 for BAYER PSA ASSAY, Substantially Equivalent on 2000-04-13. Applicant: Bayer Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Corp.
- Product code
- Code LTJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
Recent devices under product code LTJ
view allMore clearances from Bayer Corp.
view all- K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER
- K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
- K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY
- K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
- K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.