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FDA 510(k)

CHLORIDE/CARBON DIOXIDE RATE REAGENT

K-Number: K811701 · 1981-07-01

ApplicantChem-Elec, Inc.
Decision Date1981-07-01
Product CodeJFS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHLORIDE/CARBON DIOXIDE RATE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Chem-Elec, Inc.. It received FDA 510(k) clearance on 1981-07-01 under 510(k) number K811701. The device is classified under product code JFS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLORIDE/CARBON DIOXIDE RATE REAGENT?

CHLORIDE/CARBON DIOXIDE RATE REAGENT is a medical device that received FDA 510(k) clearance on 1981-07-01. The listed applicant is Chem-Elec, Inc.. The 510(k) number is K811701.

When did CHLORIDE/CARBON DIOXIDE RATE REAGENT receive FDA 510(k) clearance?

CHLORIDE/CARBON DIOXIDE RATE REAGENT received FDA 510(k) clearance on 1981-07-01, under 510(k) number K811701.

Who is the listed applicant for CHLORIDE/CARBON DIOXIDE RATE REAGENT?

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

What is the FDA product code for CHLORIDE/CARBON DIOXIDE RATE REAGENT?

The FDA product code for CHLORIDE/CARBON DIOXIDE RATE REAGENT is JFS.

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Other records listing Chem-Elec, 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.

K943503CHEMCARD GLUCOSE TESTK864159SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOODK811381ASTRAK811406CREATININE RATE REAGENT KITK811165GLUCOSE OXIDASE RATE REAGENTK811319CHLORIDE REAGENT KIT

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Related Devices (Code: JFS)

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.

K121823CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRICWescor, Inc.K923598REDI-CHECK PHOTMETER Q.A.Awareness Technology, Inc.K873127CHLORIDE REAGENT KITA-Kem, Inc.K830217REAGENTS CORNING CHLORIDE METER FORFisher Scientific Co., LLCK823106RERMCO TEST CHLORIDE REAGENTFermco Biochemics, Inc.K820411LIQUIZYME CHLORIDE REAGENTAmerican Research Products Co.

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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