FDA 510(k)

IMMU-TEC

K-Number: K841862 · 1984-06-13

Decision Date1984-06-13

Product CodeDCK

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

IMMU-TEC is the device name listed in this FDA 510(k) record. The listed applicant is Medilab Corp.. It received FDA 510(k) clearance on 1984-06-13 under 510(k) number K841862. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMU-TEC?

IMMU-TEC is a medical device that received FDA 510(k) clearance on 1984-06-13. The listed applicant is Medilab Corp.. The 510(k) number is K841862.

When did IMMU-TEC receive FDA 510(k) clearance?

IMMU-TEC received FDA 510(k) clearance on 1984-06-13, under 510(k) number K841862.

Who is the listed applicant for IMMU-TEC?

The FDA 510(k) record lists Medilab Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMU-TEC?

The FDA product code for IMMU-TEC is DCK.

Other records listing Medilab Corp. as applicant

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.