Biospace Inc.
Cerritos, CA, US
BIOSPACE INC. appears in FDA device records in Cerritos, CA. 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 Biospace Inc. between 2003 and 2014. The busiest year on record is 2013, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2005 | 2 |
| 2007 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 3 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K141483 | BIOSPACE BODY COMPOSITION ANALYZER | MNW | Substantially Equivalent | |
| K130777 | INBODY | MNW | Substantially Equivalent | |
| K131064 | BIOSPACE | DXN | Substantially Equivalent | |
| K123228 | INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) | MNW | Substantially Equivalent | |
| K110689 | INBODY | MNW | Substantially Equivalent | |
| K092786 | INBODY, MODELS: 270, R20, R20B | MNW | Substantially Equivalent | |
| K062603 | BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 | MNW | Substantially Equivalent | |
| K052646 | BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 | MNW | Substantially Equivalent | |
| K042528 | INBODY, MODEL 3.0 | MNW | Substantially Equivalent | |
| K023478 | INBODY AP1 BODY COMPOSITION ANALYZER | MNW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003193933 | 3003193933 | BIOSPACE INC. | 13850 CERRITOS CORPORATE DR STE C, Cerritos, CA 90703 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