FDA applicant

Self Care Systems, Inc.

Newport Beach, CA3 decisions1986–19860 recalls

FDA records 3 decisions for Self Care Systems, Inc. (Newport Beach, CA) in 1986: 3 510(k) clearances. Most are in product codes KHE (Reagent, Occult Blood) and GTZ (Antisera, All Groups, Streptococcus Spp.). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Self Care Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Self Care Systems, 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 “Self”

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

Self Regulation Systems, Inc. 3 Self Doctor Care, LLC 1 Self Sharpening Surgical Steel, Inc. 1

Self Care Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Self”