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FDA 510(k)

GEM-PREMIER SYSTEM

K-Number: K910305 · 1991-04-03

ApplicantMallinckrodt Sensor Systems, Inc.
Decision Date1991-04-03
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEM-PREMIER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Sensor Systems, Inc.. It received FDA 510(k) clearance on 1991-04-03 under 510(k) number K910305. 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 GEM-PREMIER SYSTEM?

GEM-PREMIER SYSTEM is a medical device that received FDA 510(k) clearance on 1991-04-03. The listed applicant is Mallinckrodt Sensor Systems, Inc.. The 510(k) number is K910305.

When did GEM-PREMIER SYSTEM receive FDA 510(k) clearance?

GEM-PREMIER SYSTEM received FDA 510(k) clearance on 1991-04-03, under 510(k) number K910305.

Who is the listed applicant for GEM-PREMIER SYSTEM?

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

What is the FDA product code for GEM-PREMIER SYSTEM?

The FDA product code for GEM-PREMIER SYSTEM 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.

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Other records listing Mallinckrodt Sensor 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.

K961335GEM PREMIER PLUS MODEL 5500

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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