Atlas FDA

Elecsys HCG STAT

FDA 510(k) clearance K203227 · decided 2021-08-18

Clearance details

K-number
K203227
Device name
Elecsys HCG STAT
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2020-11-02
Decision date
2021-08-18
Days to decision
289 days
Clearance type
Traditional
Product code
DHA
Device class
2
Regulation number
862.1155
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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RecordFirmDate
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (K233581)Ortho Clinical Diagnostics2024-05-08
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (K223690)Shenzhen Yhlo Biotech Co., Ltd.2023-12-11
Alinity i Total ß-hCG Reagent Kit, GLP systems Track (K230937)Abbott Laboratories2023-06-05
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (K230790)Abbott Laboratories2023-05-19
Access Total ßhCG (5th IS) (K221990)Beckman Coulter, Inc.2022-12-27
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer (K212221)Diazyme Laboratories, Inc.2021-12-13
ADVIA Centaur® Total hCG assay (K200210)Siemens Healthcare Diagnostics, Inc.2021-07-13
MAGLUMI 2000 HCG/ß-HCG (K192547)Shenzhen New Industries Biomedical Engineering Co., Ltd.2020-01-17
Atellica IM Total hCG (ThCG) (K192790)Siemens Healthcare Diagnostics, Inc.2019-10-30
Alinity i Total ß-hCG Reagent Kit, Alinity i System (K170317)Abbott Laboratories2017-10-23
Diazyme DZ-Lite Total beta-hCG Test System (K163418)Diazyme Laboratories2017-08-18
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (K133002)Abbott Point of Care, Inc.2015-04-16

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01