FDA applicant

Caltag Laboratories, Inc.

South San Francisco, CA12 decisions1995–19991 recall

FDA records 12 decisions for Caltag Laboratories, Inc. (South San Francisco, CA) from 1995 to 1999: 12 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and GHQ (Stain, Fetal Hemoglobin). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Caltag Laboratories, Inc. since 2007.

Recalls per year

1in 2018

2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Caltag Laboratories, Inc.’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 “Caltag”

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

Caltag Medsystems, Ltd. 1

Caltag Laboratories, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Caltag”