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FDA 510(k)

(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE

K-Number: K963627 · 1996-10-24

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1996-10-24
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1996-10-24 under 510(k) number K963627. 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 (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE?

(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE is a medical device that received FDA 510(k) clearance on 1996-10-24. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K963627.

When did (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE receive FDA 510(k) clearance?

(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE received FDA 510(k) clearance on 1996-10-24, under 510(k) number K963627.

Who is the listed applicant for (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE?

The FDA 510(k) record lists Roche Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE?

The FDA product code for (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE is JGS.

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Other records listing Roche Diagnostic Systems, 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.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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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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