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FDA 510(k)

LAB-TEK ANA TEST KIT

K-Number: K792184 · 1979-11-30

ApplicantMiles Laboratories, Inc.
Decision Date1979-11-30
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LAB-TEK ANA TEST KIT 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 1979-11-30 under 510(k) number K792184. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAB-TEK ANA TEST KIT?

LAB-TEK ANA TEST KIT is a medical device that received FDA 510(k) clearance on 1979-11-30. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K792184.

When did LAB-TEK ANA TEST KIT receive FDA 510(k) clearance?

LAB-TEK ANA TEST KIT received FDA 510(k) clearance on 1979-11-30, under 510(k) number K792184.

Who is the listed applicant for LAB-TEK ANA TEST KIT?

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 LAB-TEK ANA TEST KIT?

The FDA product code for LAB-TEK ANA TEST KIT is DHN.

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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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