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FDA 510(k)

VISIDEX REAGENT STRIPS

K-Number: K821179 · 1982-05-14

ApplicantMiles Laboratories, Inc.
Decision Date1982-05-14
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VISIDEX REAGENT STRIPS 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 1982-05-14 under 510(k) number K821179. 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 VISIDEX REAGENT STRIPS?

VISIDEX REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1982-05-14. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K821179.

When did VISIDEX REAGENT STRIPS receive FDA 510(k) clearance?

VISIDEX REAGENT STRIPS received FDA 510(k) clearance on 1982-05-14, under 510(k) number K821179.

Who is the listed applicant for VISIDEX REAGENT STRIPS?

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 VISIDEX REAGENT STRIPS?

The FDA product code for VISIDEX REAGENT STRIPS is CGA.

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Other records listing Miles Laboratories, Inc. as applicant

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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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