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FDA 510(k)

BIOSTATOR GLUCOSE ANALYZER

K-Number: K780393 · 1978-06-19

ApplicantMiles Laboratories, Inc.
Decision Date1978-06-19
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSTATOR GLUCOSE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1978-06-19 under 510(k) number K780393. 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 BIOSTATOR GLUCOSE ANALYZER?

BIOSTATOR GLUCOSE ANALYZER is a medical device that received FDA 510(k) clearance on 1978-06-19. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K780393.

When did BIOSTATOR GLUCOSE ANALYZER receive FDA 510(k) clearance?

BIOSTATOR GLUCOSE ANALYZER received FDA 510(k) clearance on 1978-06-19, under 510(k) number K780393.

Who is the listed applicant for BIOSTATOR GLUCOSE ANALYZER?

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

What is the FDA product code for BIOSTATOR GLUCOSE ANALYZER?

The FDA product code for BIOSTATOR GLUCOSE ANALYZER 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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