The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Count-a-part Plus.
| Device ID | K841809 |
| 510k Number | K841809 |
| Device Name: | COUNT-A-PART PLUS |
| Classification | Mixture, Hematology Quality Control |
| 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 | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-01 |
| Decision Date | 1984-11-30 |