FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER— 510(k) K003094
Substantially EquivalentQualigen, Inc.
FDA 510(k) clearance K003094 for FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER, Substantially Equivalent on 2000-10-25. Applicant: Qualigen, Inc.. Device class: 2.
Clearance details
- Applicant
- Qualigen, Inc.
- Product code
- Code LTJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Carlsbad, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.