510(k) K960091 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
| Applicant | Helix Diagnostics, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Mar 20, 1996 |
| Received | Jan 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960091
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2011 | Bio-Rad Laboratories Inc Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests,
Catalog No. 96DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA
The Bio-Rad Autoimmune EIA Anti-dsDNA Test is Terminated |
LRM | None listed |
| Mar 14, 2011 | Bio-Rad Laboratories Inc Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests,
Catalog No. 576DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA
The Bio-Rad Autoimmune EIA Anti-dsDNA Test Terminated |
LRM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.