510(k) Report

FDA applicant

Precision Biologicals, Inc.

Dartmouth, Nova Scotia, CA20 decisions1989–19990 recalls

FDA records 20 decisions for Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA) from 1989 to 1999: 20 510(k) clearances. Most are in product codes GJT (Plasma, Coagulation Factor Deficient) and GGN (Plasma, Coagulation Control). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Precision Biologicals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Precision Biologicals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Precision Biologicals, Inc.’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?

  • GJTPlasma, Coagulation Factor Deficient7decisions
  • GGNPlasma, Coagulation Control6decisions
  • JSMCulture Media, Non-Propagating Transport2decisions
  • GGCControl, Plasma, Abnormal2decisions
  • GJSTest, Time, Prothrombin1decision
  • GFOActivated Partial Thromboplastin1decision

Also: GGW (1).

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K952622Cryo Check Normal Human Reference PlasmaPrecision Biologicals, Inc. · 19952cite it
  • K952623Cryo Check Lupus PlasmaPrecision Biologicals, Inc. · 19952cite it
  • K952624Cryo Check Abnormal Reference Check I & IIPrecision Biologicals, Inc. · 19951cites it
  • K971219Cryo Check Inr Validation SetPrecision Biologicals, Inc. · 19971cites it

What has FDA decided for it lately?

  • K981173Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15 (1.5ML)Precision Biologicals, Inc. · 1999
  • K981174Cryo Check Factor Xii Deficient Plasma Model FDP12-10 (1.0ML) and FDP12-15 (1.5ML)Precision Biologicals, Inc. · 1999
  • K982062Cryo-Check PNP Platelet Lysate, Model PNP-10Precision Biologicals, Inc. · 1999
  • K971219Cryo Check Inr Validation SetPrecision Biologicals, Inc. · 1997
  • K971222Cryo Check Apc Resistant PlasmaPrecision Biologicals, Inc. · 1997
  • K971223Cryo Check Factor V Deficient PlasmaPrecision Biologicals, Inc. · 1997
  • K971227Cryo Check Factor X Deficient PlasmaPrecision Biologicals, Inc. · 1997
  • K971226Cryo Check Factor IX Deficient PlasmaPrecision Biologicals, Inc. · 1997

All 20 as Precision Biologicals, Inc. →