The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Amylase Reagent Catalogue Nos. 85108 And 85109.
| Device ID | K861718 |
| 510k Number | K861718 |
| Device Name: | AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109 |
| Classification | Catalytic Methods, Amylase |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | Giovanni Bucolo |
| Correspondent | Giovanni Bucolo REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-01 |
| Decision Date | 1986-05-29 |