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FDA 510(k)

HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH

K-Number: K941433 · 1994-08-02

ApplicantHichem Diagnostics
Decision Date1994-08-02
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1994-08-02 under 510(k) number K941433. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH?

HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH is a medical device that received FDA 510(k) clearance on 1994-08-02. The listed applicant is Hichem Diagnostics. The 510(k) number is K941433.

When did HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH receive FDA 510(k) clearance?

HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH received FDA 510(k) clearance on 1994-08-02, under 510(k) number K941433.

Who is the listed applicant for HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH?

The FDA 510(k) record lists Hichem Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH?

The FDA product code for HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH is JJX.

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Other records listing Hichem Diagnostics 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.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953862HICHEM ISEKCI SOLUTION KIT 70010K953863HICHEM ISE STANDARDS KIT 70011K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953860HICHEM ISE DILUENT KIT 70008

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Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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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