Affinity Biologicals Inc.
ANCASTER Ontario, CA
AFFINITY BIOLOGICALS INC. appears in FDA device records in ANCASTER Ontario, CA. FDA records list 5 510(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) clearance history
FDA records hold 5 510(k) clearances for Affinity Biologicals Inc. between 2005 and 2016. The busiest year on record is 2005, with 1. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K150144 | VisuCon-F Low Fibrinogen Control Plasma | GGN | Substantially Equivalent | |
| K110432 | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN | GGN | Substantially Equivalent | |
| K091284 | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA | GGN | Substantially Equivalent | |
| K052825 | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG | GGP | Substantially Equivalent | |
| K051054 | VISULIZE FACTOR IX ANTIGEN KIT | GGP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003485232 | 3003485232 | AFFINITY BIOLOGICALS INC. | 1348 SANDHILL DRIVE, ANCASTER Ontario L9G 4V5 CA | 2026 |
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.
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 Affinity Biologicals Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain