The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Resolve Systems Alkaline Phosphatase Test Kit.
| Device ID | K934013 |
| 510k Number | K934013 |
| Device Name: | RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Contact | Janet D Perkins |
| Correspondent | Janet D Perkins ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Product Code | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-18 |
| Decision Date | 1994-04-26 |