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 |