510(k) Report

FDA applicant

Techlab, Inc.

Blacksburg, VA36 decisions1992–20190 recalls

FDA records 36 decisions for Techlab, Inc. (Blacksburg, VA) from 1992 to 2019: 36 510(k) clearances. Most are in product codes LLH (Reagents, Clostridium Difficile Toxin) and MHJ (Cryptosporidium Spp.). Its devices cite 41 predicates, 16 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Techlab, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2009: 12017: 22018: 42019: 2
2007high 4 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Techlab, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Techlab”

FDA records each applicant name separately; these may or may not be the same firm.