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)

SYNERMED ISE REAGENTS

K-Number: K952179 · 1995-06-20

ApplicantSynermed, Inc.
Decision Date1995-06-20
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 Synermed, Inc.. It received FDA 510(k) clearance on 1995-06-20 under 510(k) number K952179. 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 1995-06-20. The listed applicant is Synermed, Inc.. The 510(k) number is K952179.

When did SYNERMED ISE REAGENTS receive FDA 510(k) clearance?

SYNERMED ISE REAGENTS received FDA 510(k) clearance on 1995-06-20, under 510(k) number K952179.

Who is the listed applicant for SYNERMED ISE REAGENTS?

The FDA 510(k) record lists Synermed, Inc. 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.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Synermed, 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.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK960793SYNERMED ENZYMATIC CO2 REAGENT KIT

View all 45 devices →

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.

↑