The following data is part of a premarket notification filed by A. J. P. Scientific, Inc. with the FDA for Hematology Slide Stainer.
Device ID | K780637 |
510k Number | K780637 |
Device Name: | HEMATOLOGY SLIDE STAINER |
Classification | Slide Stainer, Automated |
Applicant | A. J. P. SCIENTIFIC, 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 | 1978-04-17 |
Decision Date | 1978-05-19 |