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FDA 510(k)

CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000

K-Number: K990036 · 1999-03-18

ApplicantCareside, Inc.
Decision Date1999-03-18
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Careside, Inc.. It received FDA 510(k) clearance on 1999-03-18 under 510(k) number K990036. 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 CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000?

CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 is a medical device that received FDA 510(k) clearance on 1999-03-18. The listed applicant is Careside, Inc.. The 510(k) number is K990036.

When did CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 receive FDA 510(k) clearance?

CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 received FDA 510(k) clearance on 1999-03-18, under 510(k) number K990036.

Who is the listed applicant for CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000?

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

What is the FDA product code for CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000?

The FDA product code for CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 is JGS.

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Other records listing Careside, 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.

K020484CARESIDE LDHK020486CARESIDE GGTK020487CARESIDE ALTK020488CARESIDE TRGLYCERIDEK002792CARESIDE CHOLINESTERASEK001462CARESIDE HEMOGLOBIN

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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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