FASTPACK TSH IMMUNOASSAY— 510(k) K052301
Substantially EquivalentQualigen, Inc.
FDA 510(k) clearance K052301 for FASTPACK TSH IMMUNOASSAY, Substantially Equivalent on 2006-01-04. Applicant: Qualigen, Inc.. Device class: 2.
Clearance details
- Applicant
- Qualigen, Inc.
- Product code
- Code JLW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1690
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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- K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
- K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
More 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
- K101388 — FASTPACK TESTO IMMUNOASSAY
Adverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
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 K052301
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 K052301.
Data sourced from openFDA. This site is unofficial and independent of the FDA.