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FDA 510(k)

SERALYZER GLUCOSE TEST MODULE

K-Number: K801664 · 1980-08-20

ApplicantMiles Laboratories, Inc.
Decision Date1980-08-20
Product CodeJQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERALYZER GLUCOSE TEST MODULE 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 1980-08-20 under 510(k) number K801664. The device is classified under product code JQP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERALYZER GLUCOSE TEST MODULE?

SERALYZER GLUCOSE TEST MODULE is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K801664.

When did SERALYZER GLUCOSE TEST MODULE receive FDA 510(k) clearance?

SERALYZER GLUCOSE TEST MODULE received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801664.

Who is the listed applicant for SERALYZER GLUCOSE TEST MODULE?

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 SERALYZER GLUCOSE TEST MODULE?

The FDA product code for SERALYZER GLUCOSE TEST MODULE is JQP.

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Other records listing Miles Laboratories, 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.

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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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