FastPack IP Sex Hormone Binding Globulin Immunoassay— 510(k) K182521
Substantially EquivalentQualigen, Inc.
FDA 510(k) clearance K182521 for FastPack IP Sex Hormone Binding Globulin Immunoassay, Substantially Equivalent on 2019-01-29. 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
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code CDZ
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- K101390 — FASTPACK TSH IMMUNOASSAY
Recalls naming K182521
K-number listed on FDA's recall record- Z-0805-2025 — The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
- Z-1672-2020 — The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182521.
Data sourced from openFDA. This site is unofficial and independent of the FDA.