The following data is part of a premarket notification filed by Labtronix Corp. with the FDA for Labtronix Platelet Counter(l/o/c.).
| Device ID | K811084 |
| 510k Number | K811084 |
| Device Name: | LABTRONIX PLATELET COUNTER(L/O/C.) |
| Classification | Platelet Counting, Manual |
| Applicant | LABTRONIX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GLG |
| CFR Regulation Number | 864.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-21 |
| Decision Date | 1981-07-23 |