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FDA 510(k)

GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE

K-Number: K761153 · 1976-12-09

ApplicantAdvanced Biomedical Methods, Inc.
Decision Date1976-12-09
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Methods, Inc.. It received FDA 510(k) clearance on 1976-12-09 under 510(k) number K761153. 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 GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE?

GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE is a medical device that received FDA 510(k) clearance on 1976-12-09. The listed applicant is Advanced Biomedical Methods, Inc.. The 510(k) number is K761153.

When did GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE receive FDA 510(k) clearance?

GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE received FDA 510(k) clearance on 1976-12-09, under 510(k) number K761153.

Who is the listed applicant for GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE?

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

What is the FDA product code for GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE?

The FDA product code for GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE is CGA.

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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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