Atlas FDA

Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System

FDA 510(k) clearance K151792 · decided 2015-11-20

Clearance details

K-number
K151792
Device name
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2015-07-01
Decision date
2015-11-20
Days to decision
142 days
Clearance type
Traditional
Product code
JLW
Device class
2
Regulation number
862.1690
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Atellica® IM TSH3-Ultra II (TSH3ULII) (K251543)Siemens Healthcare Diagnostics, Inc.2026-02-06
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Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (K221225)Beckman Coulter, Inc.2022-11-10
Elecsys TSH (K190773)Roche Diagnostics2019-04-16
AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer (K170232)Boditech Med, Inc.2017-10-13
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Recalls involving this device

RecordFirmDate
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960 recall (Z-2404-2020)Siemens Healthcare Diagnostics, Inc.2020-06-19
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026 recall (Z-2405-2020)Siemens Healthcare Diagnostics, Inc.2020-06-19

PMA approvals by this applicant

RecordFirmDate
IMMULITE 2000 PSA (P930027/S039)Siemens Healthcare Diagnostics, Inc.2026-07-27
IMMULITE 2000 AFP (P010007/S026)Siemens Healthcare Diagnostics, Inc.2026-07-27
Atellica IM free PSA II (fPSAII) (P250026)Siemens Healthcare Diagnostics, Inc.2026-05-11
ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) (P930036/S026)Siemens Healthcare Diagnostics, Inc.2026-05-11
IMMULITE 2000 AFP (P010007/S025)Siemens Healthcare Diagnostics, Inc.2026-04-21
IMMULITE 2000 PSA (P930027/S038)Siemens Healthcare Diagnostics, Inc.2026-04-21
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