FASTPACK TESTO IMMUNOASSAY— 510(k) K101388
Substantially EquivalentQualigen, Inc.
FDA 510(k) clearance K101388 for FASTPACK TESTO IMMUNOASSAY, Substantially Equivalent on 2011-02-18. Applicant: Qualigen, Inc.. Device class: 1.
Clearance details
- Applicant
- Qualigen, 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
- Special
- Location
- Carlsbad, CA, US
Recent devices under product code CDZ
view allMore clearances from Qualigen, Inc.
view all- K182521 — FastPack IP Sex Hormone Binding Globulin Immunoassay
- K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
- K123983 — FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS
- K123725 — FASTPACK CONTROL KIT
- K101390 — FASTPACK TSH IMMUNOASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.