FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
K Number: K132515
·
Decision Nov 8, 2013
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
85
Applicant Total
71
Review Days
88
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
- LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
- K Number
- K132515
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DiaSorin, Inc.
- Date Received
- August 12, 2013
- Decision Date
- November 8, 2013
- 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 DiaSorin, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | Jun 4, 2026 | Substantially Equivalent |
| DEN250032 | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) | Dec 23, 2025 | Unknown |
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | Oct 27, 2023 | Substantially Equivalent |
| K223403 | LIAISON Anti-HAV; LIAISON XS | Dec 9, 2022 | Substantially Equivalent |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | Jul 26, 2022 | Substantially Equivalent |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set | Jul 14, 2022 | Substantially Equivalent |
| K193650 | LIAISON Ferritin | Sep 14, 2021 | Substantially Equivalent |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | Feb 18, 2021 | Substantially Equivalent |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | Feb 18, 2021 | Substantially Equivalent |
| K210272 | LIAISON Anti-HAV | Feb 9, 2021 | Substantially Equivalent |