The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Igm Rf Eia.
| Device ID | K942908 |
| 510k Number | K942908 |
| Device Name: | IGM RF EIA |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Joseph Bohn |
| Correspondent | Joseph Bohn SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-21 |
| Decision Date | 1995-01-20 |