TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT— 510(k) K032134
Substantially EquivalentKronus Market Development Associates, Inc.
FDA 510(k) clearance K032134 for TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT, Substantially Equivalent on 2003-09-10. Applicant: Kronus Market Development Associates, Inc.. Device class: 2.
Clearance details
- Applicant
- Kronus Market Development Associates, Inc.
- Product code
- Code JZO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boise, ID, US
Recent devices under product code JZO
view allMore clearances from Kronus Market Development Associates, Inc.
view all- DEN140001 — ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
- K121046 — STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
- K111956 — KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
- K080523 — KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT
- K080159 — KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.