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FDA 510(k)

CHLORIDE REAGENT

K-Number: K911297 · 1991-04-16

ApplicantIntersect Systems, Inc.
Decision Date1991-04-16
Product CodeCHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHLORIDE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Systems, Inc.. It received FDA 510(k) clearance on 1991-04-16 under 510(k) number K911297. The device is classified under product code CHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLORIDE REAGENT?

CHLORIDE REAGENT is a medical device that received FDA 510(k) clearance on 1991-04-16. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K911297.

When did CHLORIDE REAGENT receive FDA 510(k) clearance?

CHLORIDE REAGENT received FDA 510(k) clearance on 1991-04-16, under 510(k) number K911297.

Who is the listed applicant for CHLORIDE REAGENT?

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

What is the FDA product code for CHLORIDE REAGENT?

The FDA product code for CHLORIDE REAGENT is CHJ.

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Other records listing Intersect Systems, 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.

K021636ALBUMIN REAGENTK011972DIRECT BILIRUBIN REAGENTK011692HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENTK003892TOTAL BILIRUBIN REAGENTK983937DUAL VIAL CREATININE REAGENTK974833CK-NAC REAGENT

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Related Devices (Code: CHJ)

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.

K010670PICCOLO CHLORIDE TEST SYSTEMAbaxis, Inc.K945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERCatachem, Inc.K943006CHLORIDE QVETPrisma SystemsK934136OLYMPUS CHLORIDE REAGENT, MODIFICATIONOlympus Corp.K932528OLYMPUS CHLORID REAGENT, MODIFIEDOlympus Corp.K925338OLYMPUS CHLORIDE REAGENTOlympus 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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