FASTPACK CONTROL— 510(k) K003095
Substantially EquivalentQualigen, Inc.
FDA 510(k) clearance K003095 for FASTPACK CONTROL, Substantially Equivalent on 2000-11-29. Applicant: Qualigen, Inc.. Device class: 1.
Clearance details
- Applicant
- Qualigen, Inc.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Carlsbad, CA, US
Recent devices under product code JJX
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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 JJX
product code JJX- Other
- 2
- Total
- 2
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.