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FDA 510(k)

FERMCOTEST CO2 REAGNET

K-Number: K822117 · 1982-09-30

ApplicantFermco Biochemics, Inc.
Decision Date1982-09-30
Product CodeJFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FERMCOTEST CO2 REAGNET is the device name listed in this FDA 510(k) record. The listed applicant is Fermco Biochemics, Inc.. It received FDA 510(k) clearance on 1982-09-30 under 510(k) number K822117. The device is classified under product code JFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FERMCOTEST CO2 REAGNET?

FERMCOTEST CO2 REAGNET is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Fermco Biochemics, Inc.. The 510(k) number is K822117.

When did FERMCOTEST CO2 REAGNET receive FDA 510(k) clearance?

FERMCOTEST CO2 REAGNET received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822117.

Who is the listed applicant for FERMCOTEST CO2 REAGNET?

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

What is the FDA product code for FERMCOTEST CO2 REAGNET?

The FDA product code for FERMCOTEST CO2 REAGNET is JFL.

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Other records listing Fermco Biochemics, 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.

K843832TRIGLYCERIDES REAGENT SYSTEMK823106RERMCO TEST CHLORIDE REAGENTK822118FERMCOTEST CREATININE TEST REAGENTK810567GERMCO TEST R GLUCOSE TEST KITK791066GLUCOSE GOD-PAP TRINDER METHOD TEST KITK791018FERMCOTEST R BUN RATE REAGENT TEST KIT

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Related Devices (Code: JFL)

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.

K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K040975GENCHEM CO2 ACID REAGENTGenchem, Inc.K014034MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)Beckman Coulter, Inc.K963541SIGMA DIAGNOSTICS CO2 ACID REAGENTSigma Diagnostics, Inc.K963538SIGMA DIAGNOSTICS CO2ALKALINE BUFFERSigma Diagnostics, Inc.K963540SIGMA DIAGNOSTICS ELECTROLYTE BUFFERSigma Diagnostics, 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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