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FDA 510(k)

IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES

K-Number: K854423 · 1985-11-20

ApplicantDynatech Laboratories, Inc.
Decision Date1985-11-20
Product CodeLIB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Laboratories, Inc.. It received FDA 510(k) clearance on 1985-11-20 under 510(k) number K854423. The device is classified under product code LIB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES?

IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES is a medical device that received FDA 510(k) clearance on 1985-11-20. The listed applicant is Dynatech Laboratories, Inc.. The 510(k) number is K854423.

When did IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES receive FDA 510(k) clearance?

IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES received FDA 510(k) clearance on 1985-11-20, under 510(k) number K854423.

Who is the listed applicant for IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES?

The FDA 510(k) record lists Dynatech Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES?

The FDA product code for IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES is LIB.

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Related Devices (Code: LIB)

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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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