510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Precision BioLogic Inc.

Dartmouth Nova Scotia, CA

Precision BioLogic Inc. appears in FDA device records in Dartmouth Nova Scotia, CA. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
17
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 17 510(k) clearances for Precision BioLogic Inc. between 1999 and 2025. The busiest year on record is 1999, with 4. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Precision BioLogic Inc., by decision year
YearClearances
19994
20011
20033
20041
20051
20061
20191
20202
20221
20231
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251440CRYOcheck Chromogenic Factor VIIIGGPSubstantially Equivalent
K222831CRYOcheck Factor VIII Deficient Plasma with VWFGJTSubstantially Equivalent
K214002CRYOcheck Chromogenic Factor IXGGPSubstantially Equivalent
K193556Cryocheck Hex LAGFOSubstantially Equivalent
K193204Cryocheck Chromogenic Factor VIIIGGPSubstantially Equivalent
K183440CRYOcheck FVIII Inhibitor KitGGPSubstantially Equivalent
K060284CRYOCHECK CLOT APCRGGWSubstantially Equivalent
K043571CRYOCHECK CLOT SGGPSubstantially Equivalent
K040987CRYOCHECK CLOT CGGPSubstantially Equivalent
K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLGGCSubstantially Equivalent
K023991CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50JBQSubstantially Equivalent
K023990CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50GGPSubstantially Equivalent
K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10GIZSubstantially Equivalent
K990580CRYOCHECK LA SURE, MODEL SUR25-10GIRSubstantially Equivalent
K990579CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)GIRSubstantially Equivalent
K990814CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15GJTSubstantially Equivalent
K990296CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)GJTSubstantially Equivalent

Registered establishments

FDA registered establishments for Precision BioLogic Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80435993005917516Precision BioLogic Inc.140 Eileen Stubbs Avenue, Dartmouth Nova Scotia B3B 0A9 CA2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Precision BioLogic Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain