The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Isostat Microbial Tube Processing.
| Device ID | K840496 |
| 510k Number | K840496 |
| Device Name: | ISOSTAT MICROBIAL TUBE PROCESSING |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-06 |
| Decision Date | 1984-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811877010064 | K840496 | 000 |
| 00811877010098 | K840496 | 000 |
| 00811877010050 | K840496 | 000 |