The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Nitro Blue Tetrazolium Reduction.
| Device ID | K904022 |
| 510k Number | K904022 |
| Device Name: | NITRO BLUE TETRAZOLIUM REDUCTION |
| Classification | Test, Leukocyte Alkaline Phosphatase |
| Applicant | SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Takes, Ph.d |
| Correspondent | Takes, Ph.d SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | GHD |
| CFR Regulation Number | 864.7660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-30 |
| Decision Date | 1990-12-18 |