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FDA 510(k)

TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM

K-Number: K842470 · 1984-08-28

ApplicantMiles Laboratories, Inc.
Decision Date1984-08-28
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM 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 1984-08-28 under 510(k) number K842470. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM?

TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM is a medical device that received FDA 510(k) clearance on 1984-08-28. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K842470.

When did TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM receive FDA 510(k) clearance?

TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM received FDA 510(k) clearance on 1984-08-28, under 510(k) number K842470.

Who is the listed applicant for TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM?

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 TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM?

The FDA product code for TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM is DFH.

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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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