The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Deae-dextran In Pbs.
| Device ID | K834116 |
| 510k Number | K834116 |
| Device Name: | DEAE-DEXTRAN IN PBS |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-29 |
| Decision Date | 1984-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747370 | K834116 | 000 |