The following data is part of a premarket notification filed by Hml Inc/biotechnology Transfer with the FDA for Hematology Analyzer.
| Device ID | K842310 |
| 510k Number | K842310 |
| Device Name: | HEMATOLOGY ANALYZER |
| Classification | Acid, Delta-aminolevulinic, Ion-exchange Columns With Colorimetry |
| Applicant | HML INC/BIOTECHNOLOGY TRANSFER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JKL |
| CFR Regulation Number | 862.1060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-12 |
| Decision Date | 1984-09-06 |