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FDA 510(k)

Synermed ISE Reagents

K-Number: K181201 · 2018-07-10

ApplicantInfrared Laboratory Systems, LLC (Dba Synermed)
Decision Date2018-07-10
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Synermed ISE Reagents is the device name listed in this FDA 510(k) record. The listed applicant is Infrared Laboratory Systems, LLC (Dba Synermed). It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K181201. 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 Synermed ISE Reagents?

Synermed ISE Reagents is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is Infrared Laboratory Systems, LLC (Dba Synermed). The 510(k) number is K181201.

When did Synermed ISE Reagents receive FDA 510(k) clearance?

Synermed ISE Reagents received FDA 510(k) clearance on 2018-07-10, under 510(k) number K181201.

Who is the listed applicant for Synermed ISE Reagents?

The FDA 510(k) record lists Infrared Laboratory Systems, LLC (Dba Synermed) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synermed ISE Reagents?

The FDA product code for Synermed ISE Reagents is JGS.

Other records listing Infrared Laboratory Systems, LLC (Dba Synermed) 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.

K172416Synermed Opiate Enzyme ImmunoassayK153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer

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

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

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