The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Picoscale Laborscale, #psl-1 & Analyser, #psa-1.
| Device ID | K853036 |
| 510k Number | K853036 |
| Device Name: | PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge, NY 11788 |
| Contact | Robert E Lind |
| Correspondent | Robert E Lind DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge, NY 11788 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-18 |
| Decision Date | 1985-11-05 |