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FDA 510(k)

TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG

K-Number: K842468 · 1984-08-28

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

Device Summary

TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG 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 K842468. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG?

TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG 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 K842468.

When did TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG receive FDA 510(k) clearance?

TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG received FDA 510(k) clearance on 1984-08-28, under 510(k) number K842468.

Who is the listed applicant for TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG?

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 IGA/IGG?

The FDA product code for TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG is CZP.

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Related Devices (Code: CZP)

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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