FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
K Number: K063232
·
Decision Jun 19, 2007
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
85
Applicant Total
23
Review Days
237
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
- ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
- K Number
- K063232
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biokit, S.A.
- Date Received
- October 25, 2006
- Decision Date
- June 19, 2007
- Product Code
- CEW
- 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 |
|---|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEW), ordered by most recent decision date.
Elecsys PTH , Elecsys PTH STAT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Intact PTH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lumipulse G whole PTH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IDS-iSYS Intact PTHN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Biokit, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | Feb 12, 2025 | Substantially Equivalent |
| K233606 | ADVIA Centaur EBV-VCA IgM | Aug 7, 2024 | Substantially Equivalent |
| K233605 | ADVIA Centaur EBV-EBNA IgG | Aug 7, 2024 | Substantially Equivalent |
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | Sep 20, 2023 | Substantially Equivalent |
| K214068 | Quantia IgE | Feb 21, 2023 | Substantially Equivalent |
| K181334 | ADVIA Centaur Herpes-2 IgG | Aug 23, 2018 | Substantially Equivalent |
| K181333 | ADVIA Centaur Herpes-1 IgG | Aug 23, 2018 | Substantially Equivalent |
| K152185 | ARCHITECT SHBG | Feb 11, 2016 | Substantially Equivalent |
| K132400 | LP(A) CALIBRATORS, AND LP(A) CONTROLS | Dec 19, 2013 | Substantially Equivalent |
| K123947 | ARCHITECT IVANCOMYCIN | Aug 29, 2013 | Substantially Equivalent |