FDA 510(k) Applications Submitted by JOSEPH M CALIFANO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K973823 |
10/07/1997 |
PR 3 ANTIBODY KIT |
HEMAGEN DIAGNOSTICS, INC. |
| K960324 |
01/23/1996 |
HEMAGEN CRP 150 KIT (EIA METHOD) |
HEMAGEN DIAGNOSTICS, INC. |
| K971039 |
03/21/1997 |
HEMAGEN ANTI CARDIOLIPIN SCREEN |
HEMAGEN DIAGNOSTICS, INC. |
| K971909 |
05/23/1997 |
VIRGO AMA ELISA KIT |
HEMAGEN DIAGNOSTICS, INC. |
| K962276 |
06/13/1996 |
HEMAGEN ENA DSDNA KIT (EIA METHOD) |
HEMAGEN DIAGNOSTICS, INC. |
| K992224 |
07/01/1999 |
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT |
HEMAGEN DIAGNOSTICS, INC. |
| K992241 |
07/01/1999 |
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT |
HEMAGEN DIAGNOSTICS, INC. |
| K992243 |
07/01/1999 |
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT |
HEMAGEN DIAGNOSTICS, INC. |
| K962836 |
07/22/1996 |
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) |
HEMAGEN DIAGNOSTICS, INC. |
| K972812 |
07/28/1997 |
RAICHEM PREALBUMIN SPIA |
HEMAGEN DIAGNOSTICS, INC. |
| K944438 |
09/12/1994 |
HEMAGEN CMV IGG KIT |
HEMAGEN DIAGNOSTICS, INC. |
| K973822 |
10/07/1997 |
VIRGO ANCA SCREEN KIT |
HEMAGEN DIAGNOSTICS, INC. |
| K973824 |
10/07/1997 |
VIRGO PANCO KIT |
HEMAGEN DIAGNOSTICS, INC. |
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