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FDA 510(k)

TRI-COMBO PARASITE SCREEN

K-Number: K171078 · 2017-07-10

ApplicantTechlab, Inc.
Decision Date2017-07-10
Product CodeMHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRI-COMBO PARASITE SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2017-07-10 under 510(k) number K171078. The device is classified under product code MHJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-COMBO PARASITE SCREEN?

TRI-COMBO PARASITE SCREEN is a medical device that received FDA 510(k) clearance on 2017-07-10. The listed applicant is Techlab, Inc.. The 510(k) number is K171078.

When did TRI-COMBO PARASITE SCREEN receive FDA 510(k) clearance?

TRI-COMBO PARASITE SCREEN received FDA 510(k) clearance on 2017-07-10, under 510(k) number K171078.

Who is the listed applicant for TRI-COMBO PARASITE SCREEN?

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

What is the FDA product code for TRI-COMBO PARASITE SCREEN?

The FDA product code for TRI-COMBO PARASITE SCREEN is MHJ.

Other records listing Techlab, Inc. 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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