510(k) Report

FDA applicant

Provalis Diagnostics, Ltd.

Rockville, MD3 decisions2000–20044 recalls

FDA records 3 decisions for Provalis Diagnostics, Ltd. (Rockville, MD) from 2000 to 2004: 3 510(k) clearances. All are in product code LCP (Assay, Glycosylated Hemoglobin). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 recalls are 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 Provalis Diagnostics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Provalis Diagnostics, Ltd. since 2007.

Recalls per year

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • LCPAssay, Glycosylated Hemoglobin3decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K041635G5 I HBA1C Test, G5 II HBA1C TestProvalis Diagnostics, Ltd. · 20041cites it
  • K011933Glycosal II Hba 1C TestProvalis Diagnostics, Ltd. · 20011cites it

What has FDA decided for it lately?

  • K041635G5 I HBA1C Test, G5 II HBA1C TestProvalis Diagnostics, Ltd. · 20044 recalls
  • K011933Glycosal II Hba 1C TestProvalis Diagnostics, Ltd. · 2001
  • K001392Glycosal HBA1C TestProvalis Diagnostics, Ltd. · 2000

All 3 as Provalis Diagnostics, Ltd. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K041635in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges…Sep 7, 2010
  • K041635in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test…Jul 26, 2010
  • K041635Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic…Aug 3, 2006
  • K041635Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P…May 20, 2005