FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALFIS Vitamin D, ALFIS-3 Analyzer
K Number: K221817
·
Decision Sep 22, 2023
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
45
Applicant Total
14
Review Days
457
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
- ALFIS Vitamin D, ALFIS-3 Analyzer
- K Number
- K221817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1825
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunostics Inc.,
- Date Received
- June 22, 2022
- Decision Date
- September 22, 2023
- 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
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
BioPlex 2200 25-OH Vitamin D Kit
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Immunostics Inc.,
| K Number | Device Name | ||
|---|---|---|---|
| K182298 | hemochroma PLUS System | Nov 16, 2018 | Substantially Equivalent |
| K163465 | hemochroma PLUS System | Sep 8, 2017 | Substantially Equivalent |
| K163225 | AFIAS iFOB with AFIAS-50 | Aug 8, 2017 | Substantially Equivalent |
| K171484 | hema-screen SPECIFIC Gold | Jun 14, 2017 | Substantially Equivalent |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | Jan 17, 2017 | Substantially Equivalent |
| K102664 | HEMA SCREEN ER | Jan 28, 2011 | Substantially Equivalent |
| K060463 | HEMA SCREEN SPECIFIC IFOBT | Jun 6, 2006 | Substantially Equivalent |
| K041728 | HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE | Aug 11, 2004 | Substantially Equivalent |
| K031490 | RUBELLACOL | Jul 16, 2003 | Substantially Equivalent |
| K992759 | COLON ALERT TEST | Dec 6, 1999 | Substantially Equivalent |