FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS— 510(k) K123983
Substantially EquivalentQualigen, Inc.
FDA 510(k) clearance K123983 for FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS, Substantially Equivalent on 2013-07-03. Applicant: Qualigen, Inc.. Device class: 2.
Clearance details
- Applicant
- Qualigen, Inc.
- Product code
- Code MRG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1825
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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Recalls naming K123983
K-number listed on FDA's recall record- Z-3112-2017 — Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
- Z-0550-2014 — FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123983.
Data sourced from openFDA. This site is unofficial and independent of the FDA.