Atlas FDA

TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS

FDA 510(k) clearance K112343 · decided 2012-01-20

Clearance details

K-number
K112343
Device name
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2011-08-15
Decision date
2012-01-20
Days to decision
158 days
Clearance type
Traditional
Product code
LIP
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Siemens Healthcare Diagnostics

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Access Syphilis (K241427)Beckman Coulter, Inc.2024-09-06
VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534)Ortho Clinical Diagnostics2024-08-28
Elecsys Syphilis (K211302)Roche Diagnostics2021-07-20
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set (K170413)Bio-Rad Laboratories2017-05-11
Elecsys Syphilis (K160910)Roche Diagnostics2016-07-28
Lumipulse G TP-N Immunoreaction Cartridge Set (K153145)Fujirebio Diagnostics,Inc.2016-07-05
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control (K153730)Abbott Laboratories2016-06-15
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG (K120439)Bio-Rad Laboratories, Inc.2012-03-14
SYPHILIS HEALTH CHECK (K102400)Diagnostics Direct, LLC2011-08-01
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM (K102283)Zeus Scientific, Inc.2011-02-10
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM (K093837)Zeus Scientific, Inc. (Zeus)2010-10-01
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM (K091361)Siemens Healthcare Diagnostics2009-12-16

Recalls involving this device

RecordFirmDate
Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Prod recall (Z-2228-2012)Siemens Healthcare Diagnostics, Inc2012-08-20

PMA approvals by this applicant

RecordFirmDate
Atellica IM Total PSA II (tPSAII) (P240021)Siemens Healthcare Diagnostics, Inc.2025-12-03
IMMULITE 2000 PSA (P930027/S037)Siemens Healthcare Diagnostics, Inc.2025-10-30
IMMULITE 2000 AFP (P010007/S024)Siemens Healthcare Diagnostics, Inc.2025-10-30
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM Anti-HBe2 (aHBe2) (P200017/S005)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM HBc Total 2 (HBcT2) (P210019/S004)Siemens Healthcare Diagnostics, Inc.2025-10-17
IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036)Siemens Healthcare Diagnostics, Inc.2025-08-14
ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025)Siemens Healthcare Diagnostics, Inc.2025-07-16