The following data is part of a premarket notification filed by Alerchek, Inc. with the FDA for Flipscreen (tm) Total E Immunoassay.
| Device ID | K885307 |
| 510k Number | K885307 |
| Device Name: | FLIPSCREEN (TM) TOTAL E IMMUNOASSAY |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | ALERCHEK, INC. 203 ANDERSON ST. Portland, ME 04101 |
| Contact | Wayne M Henry |
| Correspondent | Wayne M Henry ALERCHEK, INC. 203 ANDERSON ST. Portland, ME 04101 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-27 |
| Decision Date | 1989-03-08 |