FASTPACK FREE T4 IMMUNOASSAY— 510(k) K030329
Substantially EquivalentQualigen, Inc.
FDA 510(k) clearance K030329 for FASTPACK FREE T4 IMMUNOASSAY, Substantially Equivalent on 2003-07-03. Applicant: Qualigen, Inc.. Device class: 2.
Clearance details
- Applicant
- Qualigen, Inc.
- Product code
- Code CEC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1695
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code CEC
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- 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
- K101388 — FASTPACK TESTO IMMUNOASSAY
Adverse events under product code CEC
product code CEC- Malfunction
- 899
- Total
- 899
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K030329
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030329.
Data sourced from openFDA. This site is unofficial and independent of the FDA.