Applied Imaging Corp.
Santa Clara, CA, US
Applied Imaging Corp. appears in FDA device records in Santa Clara, CA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Applied Imaging Corp. between 1990 and 2005. The busiest year on record is 2004, with 2. The most recent is 2005, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1998 | 1 |
| 2000 | 1 |
| 2004 | 2 |
| 2005 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K043519 | ARIOL HER-2/NEU FISH | NTH | Substantially Equivalent | |
| K042542 | CYTOVISION FOR CEP XY | NTH | Substantially Equivalent | |
| K033200 | ARIOL | NQN | Substantially Equivalent | |
| K031715 | ARIOL HER-2/NEU IHC | NOT | Substantially Equivalent | |
| K001420 | SLIDESCAN | JOY | Substantially Equivalent | |
| K980375 | WINSCAN AUTOMATED IMAGING SYSTEM | JOY | Substantially Equivalent | |
| K902311 | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | LNJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LNJAnalyzer, Chromosome, Automated
- JOYDevice, Automated Cell-Locating
- NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
- NOTMicroscope, Automated, Image Analysis, Operator Intervention
- NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain