FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FASTPACK TESTO IMMUNOASSAY
K Number: K101388
·
Decision Feb 18, 2011
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
88
Applicant Total
15
Review Days
277
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Basic Information
- Device Name
- FASTPACK TESTO IMMUNOASSAY
- K Number
- K101388
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qualigen, Inc.
- Date Received
- May 17, 2010
- Decision Date
- February 18, 2011
- Product Code
- CDZ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| K123983 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS | Jul 3, 2013 | Substantially Equivalent |
| K123725 | FASTPACK CONTROL KIT | Mar 8, 2013 | 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 |
| K022533 | FASTPACK TESTOSTERONE CALIBRATOR | Sep 30, 2002 | Substantially Equivalent |