The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Reagent For Coulter Counter Model 5+11.
| Device ID | K821683 |
| 510k Number | K821683 |
| Device Name: | REAGENT FOR COULTER COUNTER MODEL 5+11 |
| Classification | Diluent, Blood Cell |
| Applicant | FISHER SCIENTIFIC CO., LLC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GIF |
| CFR Regulation Number | 864.8200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-08 |
| Decision Date | 1982-06-24 |