510(k) Report

FDA applicant

Crestat Diagnostics, Inc.

Murrieta, CA29 decisions1990–19981 recall

FDA records 29 decisions for Crestat Diagnostics, Inc. (Murrieta, CA) from 1990 to 1998: 29 510(k) clearances. Most are in product codes CFN (Method, Nephelometric, Immunoglobulins (G, A, M)) and DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control). Its devices cite 5 predicates, 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Crestat Diagnostics, Inc. since 2007.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Crestat Diagnostics, 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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Which product codes does it file in?

  • CFNMethod, Nephelometric, Immunoglobulins (G, A, M)3decisions
  • DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control3decisions
  • DBIComplement C4, Antigen, Antiserum, Control2decisions
  • DCKC-Reactive Protein, Antigen, Antiserum, And Control2decisions
  • CIGDiazo Colorimetry, Bilirubin2decisions
  • CKBAcid Phosphatase, Naphthyl Phosphate1decision

Also: CGS (1), DDG (1), CFR (1), KQJ (1), LKL (1), CZW (1).

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K934146N-Assay Tia MicroalbuminCrestat Diagnostics, Inc. · 19942cite it
  • K964298N-Assay Tia Multi V-NLCrestat Diagnostics, Inc. · 19971cites it
  • K964297N-Assay Tia C4 Test KitCrestat Diagnostics, Inc. · 19971cites it
  • K933971N-Assay Tia IgaCrestat Diagnostics, Inc. · 19941cites it
  • K964292N-Assay Tia Apo A1 Test KitCrestat Diagnostics, Inc. · 19971cites it
  • K964296N-Assay Tia Apo B Test KitCrestat Diagnostics, Inc. · 19971cites it

What has FDA decided for it lately?

  • K980883N-Assay Glu-ULCrestat Diagnostics, Inc. · 1998
  • K981276N-Assay L D-BilCrestat Diagnostics, Inc. · 1998
  • K981289N-Assay L T-BilCrestat Diagnostics, Inc. · 1998
  • K980900N-Assay CPK-LCrestat Diagnostics, Inc. · 1998
  • K980902N-Assay L Ast/GotCrestat Diagnostics, Inc. · 1998
  • K971985N-Assay Tia Plasminogen Test KitCrestat Diagnostics, Inc. · 1997
  • K972257N-Assay Tia Antithrombin Iii Test KitCrestat Diagnostics, Inc. · 1997
  • K964292N-Assay Tia Apo A1 Test KitCrestat Diagnostics, Inc. · 1997

All 29 as Crestat Diagnostics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K965098M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and…Oct 11, 2013Class II