The following data is part of a premarket notification filed by Bio-analytics Laboratories, Inc. with the FDA for Kinetic Alkaline Phosphatase Reagent Kit.
| Device ID | K861638 |
| 510k Number | K861638 |
| Device Name: | KINETIC ALKALINE PHOSPHATASE REAGENT KIT |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | BIO-ANALYTICS LABORATORIES, INC. BOX 388 Palm City, FL 34990 |
| Contact | William J Barry |
| Correspondent | William J Barry BIO-ANALYTICS LABORATORIES, INC. BOX 388 Palm City, FL 34990 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-30 |
| Decision Date | 1986-05-29 |