FDA applicant

Quantimetrix Corp.

Redondo Beach, CA39 decisions1983–20163 recalls

FDA records 39 decisions for Quantimetrix Corp. (Redondo Beach, CA) from 1983 to 2016: 39 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JJX (Single (Specified) Analyte Controls (Assayed…). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Quantimetrix Corporation”.

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 Quantimetrix Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2007

2007high 3 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Quantimetrix Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Quantimetrix”

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

Quantimetrix Medical Industries 8

Quantimetrix Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Quantimetrix”