Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043599

FEI Number

3005917516

Entity Name

Precision BioLogic Inc.

City/State/Country

Dartmouth Nova Scotia, CA

Establishment Address

140 Eileen Stubbs Avenue, Dartmouth Nova Scotia B3B 0A9, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Precision BioLogic (Owner Number: 9002573)

Owner / Operator Contact Address

140 Eileen Stubbs Avenue, Dartmouth, CA-NS B3B 0A9, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K990579

PMA Number

N/A

All Registered Proprietary Names

CRYOCHECK Factor X Deficient Plasma CRYOCHECK LA Sure CRYOCHECK Factor XI Deficient Plasma CRYOCHECK FVIII Inhibitor Kit CRYOCHECK Factor V Deficient Plasma CRYOCHECK Abnormal 1 Reference Control CRYOCHECK Abnormal 2 Reference Control CRYOCHECK Low Fibrinogen Control Cryocheck Hex LA CRYOCHECK Platelet Lysate Cryocheck Chromogenic Factor VIII CRYOCHECK Normal Reference Plasma CRYOCHECK Lupus Positive Control CRYOCHECK Abnormal 2 Control CRYOCHECK Pooled Normal Plasma CRYOCHECK Abnormal 1 Control CRYOCHECK Factor XII Deficient Plasma CRYOCHECK Clot C Cryocheck Lupus Negative Control CRYOCHECK Weak Lupus Positive Control CRYOCHECK Prekallikrein Deficient Plasma CRYOCHECK LA Check

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-04
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2007-12-04
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-04
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2019-03-15
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2019-03-15
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-04
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2007-12-04
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-04
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-04
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2020-11-02
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2007-12-04
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2020-07-21
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-04
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-04
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2007-12-04
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-04
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-04
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-04
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2020-02-24
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2007-12-04
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-04
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2007-12-04

Official Correspondent

Karen Black

US Agent Details

Gordon Ens Business: Ens Consulting Group, LLC Email: clotterman@aol.com Phone: (316) 6803330

Related Public Records

Same Entity

Precision BioLogic

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K934605	American Bioproducts Co.	STAGO FACTOR V-DEFICIENT PLASMA	1994-03-01
K180486	Instrumentation Laboratory CO	HemosIL Factor XII Deficient Plasma	2018-03-22
K043459	Instrumentation Laboratory CO	HEMOSIL FACTOR XII DEFICIENT PLASMA	2005-02-09
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14
K010379	Instrumentation Laboratory CO	IL TEST FREE PROTEIN S	2001-04-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0736-2016	Instrumentation Laboratory Co.	2	HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Z-1519-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems
Z-0514-2014	Instrumentation Laboratory Co.	2	HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014	Instrumentation Laboratory Co.	2	HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014	Instrumentation Laboratory Co.	2	HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043599. Last updated year: 2026. Please use registration number 8043599 when referencing this establishment in official correspondence.