Atlas FDA

ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY

FDA 510(k) clearance K133601 · decided 2014-02-05

Clearance details

K-number
K133601
Device name
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2013-11-25
Decision date
2014-02-05
Days to decision
72 days
Clearance type
Traditional
Product code
CEW
Device class
2
Regulation number
862.1545
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS (K132515)DiaSorin, Inc.2013-11-08
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IDS-ISYS INTACT PTH (K103325)Immunodiagnostic Systems , Ltd.2012-02-03
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT (K101921)Ortho-Clinical Diagnostics2010-10-22
ROCHE ELECSYS PTH TEST SYSTEM (K070709)Roche Diagnostics Corp.2007-07-13

Recalls involving this device

No recalls on record reference this clearance.

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