The following data is part of a premarket notification filed by Bartels, Inc. with the FDA for Zymmune Autoreader-f Fluorescence Microplate Reader.
| Device ID | K962499 |
| 510k Number | K962499 |
| Device Name: | ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER |
| Classification | Fluorometer |
| Applicant | BARTELS, INC. 2005 N.W. SAMMAMISH RD., #107 Issaquah, WA 98027 |
| Contact | Rebecca D Fuller |
| Correspondent | Rebecca D Fuller BARTELS, INC. 2005 N.W. SAMMAMISH RD., #107 Issaquah, WA 98027 |
| Product Code | JZT |
| CFR Regulation Number | 866.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-26 |
| Decision Date | 1996-09-05 |
| Summary: | summary |