The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Hema-tek Ii Slide Stainer.
| Device ID | K771559 |
| 510k Number | K771559 |
| Device Name: | HEMA-TEK II SLIDE STAINER |
| Classification | Slide Stainer, Automated |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPA |
| CFR Regulation Number | 864.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-15 |
| Decision Date | 1977-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596563 | K771559 | 000 |