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FDA 510(k)

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)

K-Number: K161954 · 2017-03-09

ApplicantSiemens Healthcare Diagnostics
Decision Date2017-03-09
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2017-03-09 under 510(k) number K161954. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)?

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) is a medical device that received FDA 510(k) clearance on 2017-03-09. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K161954.

When did Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) receive FDA 510(k) clearance?

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) received FDA 510(k) clearance on 2017-03-09, under 510(k) number K161954.

Who is the listed applicant for Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)?

The FDA product code for Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) is JGS.

Other records listing Siemens Healthcare Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253528Atellica IM CA 19-9 IIPMA P930027Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P010007KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSK261364Atellica CH Acetaminophen 2 (ACTM)PMA P930036KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSPMA P250026Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

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Related Devices (Code: JGS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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