The following data is part of a premarket notification filed by Interlab S.r.l. with the FDA for Interlab Acid Hemoglobin Electrophoresis Test System.
| Device ID | K040146 |
| 510k Number | K040146 |
| Device Name: | INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM |
| Classification | Abnormal Hemoglobin Quantitation |
| Applicant | INTERLAB S.R.L. 150 CHERRY LANE RD. East Stroudsburg, PA 18301 -8804 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus INTERLAB S.R.L. 150 CHERRY LANE RD. East Stroudsburg, PA 18301 -8804 |
| Product Code | GKA |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-22 |
| Decision Date | 2004-05-04 |
| Summary: | summary |