Company ยท US
General Atomics
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2009. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2009 | K082488 | DIAZYME LP(A) ASSAY General Atomics | DFC |
| Jul 16, 2008 | K072977 | DIAZYME APOLIPOPROTEIN A-1 ASSAY General Atomics | MSJ |
| Jan 22, 2008 | K072523 | DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS General Atomics | LBR |
| Jun 28, 2005 | K050178 | HBA1C ENZYMATIC ASSAY General Atomics | LCP |
| Oct 29, 2004 | K042448 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT General Atomics | JJX |
| Dec 23, 2003 | K033360 | DIAZYME LITHIUM ENZYMATIC ASSAY KIT General Atomics | JII |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||