Bio-Research Associates, Inc.
Mequon, WI, US
BIO-RESEARCH ASSOCIATES, INC. appears in FDA device records in Mequon, WI. FDA records list 10 510(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 10 510(k) clearances for Bio-Research Associates, Inc. between 1982 and 2013. The busiest year on record is 1982, with 1. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1985 | 1 |
| 1988 | 1 |
| 1995 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2006 | 1 |
| 2009 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130158 | M-SCAN | KZM | Substantially Equivalent | |
| K082927 | BIOEMG III | KZM | Substantially Equivalent | |
| K061799 | QUADRATENS, MODEL QT-42 | GZJ | Substantially Equivalent | |
| K003176 | BIOEMG II AND BIOJVA | KZM | Substantially Equivalent | |
| K991756 | 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE | DQD | Substantially Equivalent | |
| K981563 | BIOPAK MEASUREMENT SYSTEM | KZM | Substantially Equivalent | |
| K952218 | JT-3 ELECTROGNATHOGRAPH | NFS | Substantially Equivalent | |
| K873947 | BIO-EMG MODEL 800 | KZM | Substantially Equivalent | |
| K844618 | BIO-TENS | GZJ | Substantially Equivalent | |
| K822565 | NEEDLE CATHETER JEJUNOSTOMY KIT | KNT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183552 | 2183552 | BIO-RESEARCH ASSOCIATES, INC. | 12308 Corporate Pkwy Ste 450, Mequon, WI 53092 US | 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
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Data as of , FDA export datePage updated Source: openFDA, public domain