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FDA 510(k)

I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK

K-Number: K912387 · 1991-07-01

ApplicantI-Stat Corp.
Decision Date1991-07-01
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK is the device name listed in this FDA 510(k) record. The listed applicant is I-Stat Corp.. It received FDA 510(k) clearance on 1991-07-01 under 510(k) number K912387. 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 I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK?

I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK is a medical device that received FDA 510(k) clearance on 1991-07-01. The listed applicant is I-Stat Corp.. The 510(k) number is K912387.

When did I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK receive FDA 510(k) clearance?

I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK received FDA 510(k) clearance on 1991-07-01, under 510(k) number K912387.

Who is the listed applicant for I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK?

The FDA 510(k) record lists I-Stat Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK?

The FDA product code for I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK is JGS.

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Other records listing I-Stat Corp. 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.

K012478MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZERK011478I-STAT SYSTEMK001387I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300K001154I-STAT MODEL 200 PORTABLE CLINICAL ANALYZERK992571I-STAT SYSTEMK982071I-STAT LACTATE TEST

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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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