The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Tissue-tek V.i.p. 100/200.
| Device ID | K831313 |
| 510k Number | K831313 |
| Device Name: | TISSUE-TEK V.I.P. 100/200 |
| Classification | Processor, Tissue, Automated |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IEO |
| CFR Regulation Number | 864.3875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-22 |
| Decision Date | 1983-07-28 |