FDA 510(k) Applications Submitted by Joseph Fan
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K973823 |
10/07/1997 |
PR 3 ANTIBODY KIT |
HEMAGEN DIAGNOSTICS, INC. |
| K180771 |
03/23/2018 |
Acro HCG Pregnancy Rapid Test |
ACRO Biotech, Inc. |
| K172512 |
08/21/2017 |
ACRO HCG Pregnancy Rapid Test |
ACRO Biotech, 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. |
| K971117 |
03/27/1997 |
WARMETTE |
OLYMPIC MEDICAL CORP. |
| K001056 |
04/03/2000 |
OLYMPIC WARM-UP |
OLYMPIC MEDICAL CORP. |
| K971601 |
05/01/1997 |
OLYMPIC BILI-BASSINET |
OLYMPIC MEDICAL CORP. |
| K972193 |
06/10/1997 |
OLYMPIX MINI-PASTEURMATIC (58210) |
OLYMPIC MEDICAL CORP. |
| K955357 |
10/23/1995 |
OLYMPIC SMART SCALE MODEL 50/50RA |
OLYMPIC MEDICAL CORP. |
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