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FDA 510(k)

GLUCOSE REAGENT

K-Number: K791685 · 1979-09-17

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

Device Summary

GLUCOSE 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 K791685. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE REAGENT?

GLUCOSE 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 K791685.

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

GLUCOSE REAGENT received FDA 510(k) clearance on 1979-09-17, under 510(k) number K791685.

Who is the listed applicant for GLUCOSE 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 GLUCOSE REAGENT?

The FDA product code for GLUCOSE REAGENT is CGA.

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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: CGA)

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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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