The following data is part of a premarket notification filed by Integrated Medical Systems Int'l., Inc. with the FDA for Calibration Reference I & Ii.
| Device ID | K855035 |
| 510k Number | K855035 |
| Device Name: | CALIBRATION REFERENCE I & II |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | INTEGRATED MEDICAL SYSTEMS INT'L., INC. 316 ASH ST. Mc Allen, TX 78501 |
| Contact | James Lenar |
| Correspondent | James Lenar INTEGRATED MEDICAL SYSTEMS INT'L., INC. 316 ASH ST. Mc Allen, TX 78501 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-17 |
| Decision Date | 1986-03-17 |