FDA 510(k) Applications Submitted by ABBOTT MOLECULAR, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K212778 |
09/01/2021 |
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) |
Abbott Molecular, Inc. |
| DEN130010 |
04/09/2013 |
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) |
ABBOTT MOLECULAR, INC. |
| K131508 |
05/24/2013 |
VYSIS D7S486/CEP 7 FISH PROBE KIT |
ABBOTT MOLECULAR, INC. |
| K100015 |
01/04/2010 |
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 |
ABBOTT MOLECULAR, INC. |
| K091960 |
07/01/2009 |
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 |
ABBOTT MOLECULAR, INC. |
| K092704 |
09/03/2009 |
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 |
ABBOTT MOLECULAR, INC. |
| K080739 |
03/17/2008 |
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT |
ABBOTT MOLECULAR, INC. |
| K092705 |
09/03/2009 |
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 |
ABBOTT MOLECULAR, INC. |
| K140354 |
02/12/2014 |
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG |
ABBOTT MOLECULAR, INC. |
| K202977 |
09/30/2020 |
Alinity m STI Assay |
Abbott Molecular, Inc. |
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