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FDA 510(k)

I-STAT CONTROL LEVELS 1,2,3

K-Number: K934641 · 1993-12-09

ApplicantI-Stat Corp.
Decision Date1993-12-09
Product CodeJJR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-STAT CONTROL LEVELS 1,2,3 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 1993-12-09 under 510(k) number K934641. The device is classified under product code JJR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STAT CONTROL LEVELS 1,2,3?

I-STAT CONTROL LEVELS 1,2,3 is a medical device that received FDA 510(k) clearance on 1993-12-09. The listed applicant is I-Stat Corp.. The 510(k) number is K934641.

When did I-STAT CONTROL LEVELS 1,2,3 receive FDA 510(k) clearance?

I-STAT CONTROL LEVELS 1,2,3 received FDA 510(k) clearance on 1993-12-09, under 510(k) number K934641.

Who is the listed applicant for I-STAT CONTROL LEVELS 1,2,3?

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 CONTROL LEVELS 1,2,3?

The FDA product code for I-STAT CONTROL LEVELS 1,2,3 is JJR.

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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: JJR)

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.

K990971EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816Medica Corp.K960592ELECTROLYTE STANDARDSPhoenix Diagnostics, Inc.K955630RNA MEDICAL HEMAT CONTROLBionostics, Inc.K951435AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIALAalto Scientific, Ltd.K943925SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTINGQuantimetrix Corp.K912513ELECTROLYTE CONTROLVerichem Laboratories, Inc.

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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