The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Pha-2 Conversion Program For Platelet Analysis.
Device ID | K860586 |
510k Number | K860586 |
Device Name: | PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS |
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 | 1986-02-19 |
Decision Date | 1986-05-07 |