FDA applicant

Specialized Assays, Inc.

Pipersville, PA3 decisions1997–19970 recalls

FDA records 3 decisions for Specialized Assays, Inc. (Pipersville, PA) in 1997: 3 510(k) clearances. All are in product code JJT (Enzyme Controls (Assayed And Unassayed)). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Specialized Assays, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Specialized Assays, 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 “Specialized”

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

Specialized Health Products, Inc. 4 Specialized Health Products International, Inc. 2 Specialized Laboratory Equipment, Ltd. 2 Specialized Health Products, Intl. 1

Specialized Assays, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Specialized”