FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS
K Number: K123983
·
Decision Jul 3, 2013
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
45
Applicant Total
15
Review Days
189
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS
- K Number
- K123983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1825
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qualigen, Inc.
- Date Received
- December 26, 2012
- Decision Date
- July 3, 2013
- Product Code
- MRG
- 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 |
|---|---|---|---|
| MRG | System, Test, Vitamin D | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRG), ordered by most recent decision date.
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALFIS Vitamin D, ALFIS-3 Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access 25(OH) Vitamin D Total
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys Vitamin D total III
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Centaur Vitamin D Total (VitD)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAGLUMI 2000 25-OH Vitamin D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| 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 |
| K022533 | FASTPACK TESTOSTERONE CALIBRATOR | Sep 30, 2002 | Substantially Equivalent |