Company ยท US
Applied Imaging Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2005. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JOY | Device, Automated Cell-Locating | 2 |
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | 2 |
| LNJ | Analyzer, Chromosome, Automated | 1 |
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | 1 |
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 2005 | K043519 | ARIOL HER-2/NEU FISH Applied Imaging Corp. | NTH |
| Jan 10, 2005 | K042542 | CYTOVISION FOR CEP XY Applied Imaging Corp. | NTH |
| Mar 18, 2004 | K033200 | ARIOL Applied Imaging Corp. | NQN |
| Jan 8, 2004 | K031715 | ARIOL HER-2/NEU IHC Applied Imaging Corp. | NOT |
| Aug 30, 2000 | K001420 | SLIDESCAN Applied Imaging Corp. | JOY |
| Jun 9, 1998 | K980375 | WINSCAN AUTOMATED IMAGING SYSTEM Applied Imaging Corp. | JOY |
| Aug 20, 1990 | K902311 | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. Applied Imaging Corp. | LNJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||