The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Amylase Reagent Cs-726.
| Device ID | K844168 |
| 510k Number | K844168 |
| Device Name: | AMYLASE REAGENT CS-726 |
| Classification | Amyloclastic, Amylase |
| 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 | CJA |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-25 |
| Decision Date | 1984-11-20 |