510(k) K961053 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
SERAQUEST RUBELLA IGG
| Applicant | Quest Intl., Inc., North Miami FL, US |
| Decision | Substantially Equivalent, Sep 4, 1996 |
| Received | Mar 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961053
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2011 | Bio-Rad Laboratories Software CD is labeled in part:
"BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***"
The EVOLIS Assay Protocol Files (APF) Software contains assay-specific Terminated |
LFX | None listed |
| Mar 2, 2010 | Bio-Rad Laboratories Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Labor Terminated |
LFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.