The following data is part of a premarket notification filed by Novamed Ltd. with the FDA for Chromostreak.
| Device ID | K000718 |
| 510k Number | K000718 |
| Device Name: | CHROMOSTREAK |
| Classification | Culture Media, Propagating Transport |
| Applicant | NOVAMED LTD. 28 PIERRE KOENIG ST., TALPIOT INDUSTRIAL AREA Jerusalem, IL 93469 |
| Contact | Gerald M Slutzky |
| Correspondent | Gerald M Slutzky NOVAMED LTD. 28 PIERRE KOENIG ST., TALPIOT INDUSTRIAL AREA Jerusalem, IL 93469 |
| Product Code | JSN |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-03 |
| Decision Date | 2000-08-24 |