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FDA 510(k)

CO2 CUP REAGENT

K-Number: K791686 · 1979-09-17

ApplicantHi Chem, Inc.
Decision Date1979-09-17
Product CodeJFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CO2 CUP REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1979-09-17 under 510(k) number K791686. 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 CO2 CUP REAGENT?

CO2 CUP REAGENT is a medical device that received FDA 510(k) clearance on 1979-09-17. The listed applicant is Hi Chem, Inc.. The 510(k) number is K791686.

When did CO2 CUP REAGENT receive FDA 510(k) clearance?

CO2 CUP REAGENT received FDA 510(k) clearance on 1979-09-17, under 510(k) number K791686.

Who is the listed applicant for CO2 CUP REAGENT?

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

What is the FDA product code for CO2 CUP REAGENT?

The FDA product code for CO2 CUP REAGENT is JFL.

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Other records listing Hi Chem, 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.

K960084HICHEM GLUCOSE/HK REAGENT KITK951818HICHEM ALT REAGENT KITK943684HICHEM ENZYME VERIFIER KITK941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808K902673HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STNDK863617ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)

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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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