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FDA 510(k)

I-STAT(TM) LEVELS 1,2,3 CONTROLS

K-Number: K921477 · 1992-11-02

ApplicantI-Stat Corp.
Decision Date1992-11-02
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-STAT(TM) LEVELS 1,2,3 CONTROLS 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 1992-11-02 under 510(k) number K921477. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STAT(TM) LEVELS 1,2,3 CONTROLS?

I-STAT(TM) LEVELS 1,2,3 CONTROLS is a medical device that received FDA 510(k) clearance on 1992-11-02. The listed applicant is I-Stat Corp.. The 510(k) number is K921477.

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

I-STAT(TM) LEVELS 1,2,3 CONTROLS received FDA 510(k) clearance on 1992-11-02, under 510(k) number K921477.

Who is the listed applicant for I-STAT(TM) LEVELS 1,2,3 CONTROLS?

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(TM) LEVELS 1,2,3 CONTROLS?

The FDA product code for I-STAT(TM) LEVELS 1,2,3 CONTROLS is JJY.

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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: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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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