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FDA 510(k)

NEOCHROME II GLUCOSE, #4044

K-Number: K792534 · 1980-01-16

ApplicantAmerican Monitor Corp.
Decision Date1980-01-16
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEOCHROME II GLUCOSE, #4044 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 1980-01-16 under 510(k) number K792534. 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 II GLUCOSE, #4044?

NEOCHROME II GLUCOSE, #4044 is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is American Monitor Corp.. The 510(k) number is K792534.

When did NEOCHROME II GLUCOSE, #4044 receive FDA 510(k) clearance?

NEOCHROME II GLUCOSE, #4044 received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792534.

Who is the listed applicant for NEOCHROME II GLUCOSE, #4044?

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 II GLUCOSE, #4044?

The FDA product code for NEOCHROME II GLUCOSE, #4044 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.

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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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