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FDA 510(k)

NEOCHROME(R) III GLUCOSE

K-Number: K892002 · 1989-06-12

ApplicantAmerican Monitor Corp.
Decision Date1989-06-12
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEOCHROME(R) III GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1989-06-12 under 510(k) number K892002. 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 NEOCHROME(R) III GLUCOSE?

NEOCHROME(R) III GLUCOSE is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is American Monitor Corp.. The 510(k) number is K892002.

When did NEOCHROME(R) III GLUCOSE receive FDA 510(k) clearance?

NEOCHROME(R) III GLUCOSE received FDA 510(k) clearance on 1989-06-12, under 510(k) number K892002.

Who is the listed applicant for NEOCHROME(R) III GLUCOSE?

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

What is the FDA product code for NEOCHROME(R) III GLUCOSE?

The FDA product code for NEOCHROME(R) III GLUCOSE is CGA.

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Other records listing American Monitor Corp. 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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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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