Company ยท AU
Vital Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2012. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2014 | Vital Diagnostics, Inc. Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use
PN: 1429
For the quantitative measurement of calcium in plasma and serum Terminated |
CJY | K120626 |
| Jan 14, 2014 | Vital Diagnostics, Inc. Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use.
PN 55285
For the quantitative measurement of calcium in plasma and serum Terminated |
CJY | K120626 |
| Jun 22, 2010 | Vital Diagnostics, Inc. Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy.
Slider allows a larger lab Terminated |
GHC | None listed |
| Apr 6, 2010 | Vital Diagnostics, Inc. ATAC Serum Control Kit.
The device is used for monitoring the performance of clinical chemistry methods within the clinical range. Terminated |
JJY | K040273 |
| Apr 6, 2010 | Vital Diagnostics, Inc. Envoy 500 Serum Control Kit.
The device is used for monitoring the performance of clinical chemistry methods within the clinical range. Terminated |
JJY | K040273 |