The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Hematology Stain Pack.
| Device ID | K853241 |
| 510k Number | K853241 |
| Device Name: | HEMATOLOGY STAIN PACK |
| Classification | Wright's Stain |
| Applicant | FISHER SCIENTIFIC CO., LLC. 1 REAGENT LN. Fair Lawn, NJ 07410 |
| Contact | Jack C Mclaughlin |
| Correspondent | Jack C Mclaughlin FISHER SCIENTIFIC CO., LLC. 1 REAGENT LN. Fair Lawn, NJ 07410 |
| Product Code | IAF |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-01 |
| Decision Date | 1985-08-19 |