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FDA 510(k)

I-STAT IONIZED CALCIUM TEST

K-Number: K934642 · 1993-12-17

ApplicantI-Stat Corp.
Decision Date1993-12-17
Product CodeJFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-STAT IONIZED CALCIUM TEST 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 1993-12-17 under 510(k) number K934642. The device is classified under product code JFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STAT IONIZED CALCIUM TEST?

I-STAT IONIZED CALCIUM TEST is a medical device that received FDA 510(k) clearance on 1993-12-17. The listed applicant is I-Stat Corp.. The 510(k) number is K934642.

When did I-STAT IONIZED CALCIUM TEST receive FDA 510(k) clearance?

I-STAT IONIZED CALCIUM TEST received FDA 510(k) clearance on 1993-12-17, under 510(k) number K934642.

Who is the listed applicant for I-STAT IONIZED CALCIUM TEST?

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 IONIZED CALCIUM TEST?

The FDA product code for I-STAT IONIZED CALCIUM TEST is JFP.

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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: JFP)

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.

K230300i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical CorporationK152327EasyLyte Na/K/Cl/Ca AnalyzerMedica CorporationK984299AVL OPTI CRITICAL CARE ANALYZERAvl Scientific Corp.K972673AVL 9181 ELECTROLYTE ANALYZERAvl Scientific Corp.

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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