The following data is part of a premarket notification filed by Applied Spectral Imaging, Ltd. with the FDA for Bandview System.
| Device ID | K012103 |
| 510k Number | K012103 |
| Device Name: | BANDVIEW SYSTEM |
| Classification | Analyzer, Chromosome, Automated |
| Applicant | APPLIED SPECTRAL IMAGING, LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman APPLIED SPECTRAL IMAGING, LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | LNJ |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-05 |
| Decision Date | 2001-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016630015 | K012103 | 000 |
| 07290016630008 | K012103 | 000 |
| 07290016630039 | K012103 | 000 |