The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for For The Deter. Of Hemoglobin In Plasma #527.
| Device ID | K880038 |
| 510k Number | K880038 |
| Device Name: | FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Leo Bressler |
| Correspondent | Leo Bressler SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-05 |
| Decision Date | 1988-04-21 |