The following data is part of a premarket notification filed by Bio-analytics Laboratories, Inc. with the FDA for Enzymatic Alpha-amylase Reagent Kit.
| Device ID | K850639 |
| 510k Number | K850639 |
| Device Name: | ENZYMATIC ALPHA-AMYLASE REAGENT KIT |
| Classification | Starch-dye Bound Polymer, Amylase |
| Applicant | BIO-ANALYTICS LABORATORIES, INC. ONE BIO-ANALYTICS PLACE BOX 333 Palm City, FL 33490 |
| Contact | Roy |
| Correspondent | Roy BIO-ANALYTICS LABORATORIES, INC. ONE BIO-ANALYTICS PLACE BOX 333 Palm City, FL 33490 |
| Product Code | CIW |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-03-05 |