FDA applicant

Sierra Diagnostics

Washington, DC1 decision1999–19990 recalls

FDA records 1 decision for Sierra Diagnostics (Washington, DC) in 1999: 1 510(k) clearance. All are in product code LSL (Dna-Reagents, Neisseria). 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 Sierra Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sierra Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Sierra”

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

Sierra Laboratories, Inc. 12 Sierra Scientific Instruments, Inc. 2 Sierra Medical Devices 2 Sierra Corp. 1 Sierra Diagnostic, LLC 1 Sierra Biosearch, Inc. 1 Sierra Surgical, Inc. 1 Sierra Battery, Inc. 1

Sierra Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sierra”