Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Atellica CH Magnesium (Mg)

K-Number: K162399 · 2017-01-19

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2017-01-19
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Atellica CH Magnesium (Mg) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K162399. The device is classified under product code JGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atellica CH Magnesium (Mg)?

Atellica CH Magnesium (Mg) is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K162399.

When did Atellica CH Magnesium (Mg) receive FDA 510(k) clearance?

Atellica CH Magnesium (Mg) received FDA 510(k) clearance on 2017-01-19, under 510(k) number K162399.

Who is the listed applicant for Atellica CH Magnesium (Mg)?

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

What is the FDA product code for Atellica CH Magnesium (Mg)?

The FDA product code for Atellica CH Magnesium (Mg) is JGJ.

Other records listing Siemens Healthcare Diagnostics, Inc. 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

View all 87 devices →

Related Devices (Code: JGJ)

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.

K181748MagnesiumAbbott LaboratoriesK173294MagnesiumAbbott LaboratoriesK162200Randox RX Daytona Plus Magnesium (MG)Randox Laboratories, Ltd.

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.

↑