FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
K Number: K003094
·
Decision Oct 25, 2000
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
33
Applicant Total
15
Review Days
22
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Basic Information
- Device Name
- FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
- K Number
- K003094
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qualigen, Inc.
- Date Received
- October 3, 2000
- Decision Date
- October 25, 2000
- Product Code
- LTJ
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FDA class 2 | Immunology |
Similar 510(k) Clearances
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COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
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PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Qualigen, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | Jan 29, 2019 | Substantially Equivalent |
| 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 | Jan 7, 2015 | Substantially Equivalent |
| K123983 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS | Jul 3, 2013 | Substantially Equivalent |
| K123725 | FASTPACK CONTROL KIT | Mar 8, 2013 | Substantially Equivalent |
| K101388 | FASTPACK TESTO IMMUNOASSAY | Feb 18, 2011 | Substantially Equivalent |
| K101390 | FASTPACK TSH IMMUNOASSAY | Aug 13, 2010 | Substantially Equivalent |
| K072264 | FASTPACK HCG IMMUNOASSAY | Dec 6, 2007 | Substantially Equivalent |
| K062957 | FASTPACK TOTAL PSA METHOD VERIFICATION KIT | Apr 2, 2007 | Substantially Equivalent |
| K052301 | FASTPACK TSH IMMUNOASSAY | Jan 4, 2006 | Substantially Equivalent |
| K030329 | FASTPACK FREE T4 IMMUNOASSAY | Jul 3, 2003 | Substantially Equivalent |