The following data is part of a premarket notification filed by Interlab S.r.l. with the FDA for Microgel Alkaline Hemoglobin Electrophoresis Test System, Microgel Acid Hemoglobin Electrophoresis Test System.
| Device ID | K053571 |
| 510k Number | K053571 |
| Device Name: | MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM |
| Classification | System, Analysis, Electrophoretic Hemoglobin |
| Applicant | INTERLAB S.R.L. 150 CHERRY LANE ROAD East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus INTERLAB S.R.L. 150 CHERRY LANE ROAD East Stroudsburg, PA 18301 |
| Product Code | JBD |
| CFR Regulation Number | 864.7440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-22 |
| Decision Date | 2006-06-30 |