The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Flow Cytometry Fitc/pe Compensation Kit.
| Device ID | K910255 |
| 510k Number | K910255 |
| Device Name: | FLOW CYTOMETRY FITC/PE COMPENSATION KIT |
| Classification | Calibrator, Surrogate |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | Peter A Takes |
| Correspondent | Peter A Takes SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | JIW |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-04-03 |