The following data is part of a premarket notification filed by Perceptive Systems, Inc. with the FDA for Perceptive Systems Inc Psicom 217 Karyotyping Syst.
| Device ID | K861974 |
| 510k Number | K861974 |
| Device Name: | PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST |
| Classification | Analyzer, Chromosome, Automated |
| Applicant | PERCEPTIVE SYSTEMS, INC. 1301 REGENTS PARK DR. Houston, TX 77058 |
| Contact | Richard Tompkins |
| Correspondent | Richard Tompkins PERCEPTIVE SYSTEMS, INC. 1301 REGENTS PARK DR. Houston, TX 77058 |
| Product Code | LNJ |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-21 |
| Decision Date | 1986-08-04 |