The following data is part of a premarket notification filed by Flow Cytometry Standards Corp. with the FDA for Fluorescent Microbead Alignment Standards Tm.
| Device ID | K851450 |
| 510k Number | K851450 |
| Device Name: | FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM |
| Classification | Calibrator, Surrogate |
| Applicant | FLOW CYTOMETRY STANDARDS CORP. P.O. BOX 12621 Research Triangle Park, NC 27709 |
| Contact | Schwartz |
| Correspondent | Schwartz FLOW CYTOMETRY STANDARDS CORP. P.O. BOX 12621 Research Triangle Park, NC 27709 |
| Product Code | JIW |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-11 |
| Decision Date | 1985-09-16 |