The following data is part of a premarket notification filed by Alerchek, Inc. with the FDA for Flipscreen Specific E (pe, Se, Ne, Sw, Nw) Assay.
| Device ID | K860027 |
| 510k Number | K860027 |
| Device Name: | FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | ALERCHEK, INC. 203 ANDERSON ST. Portland, ME 04101 |
| Contact | Wayne Henry |
| Correspondent | Wayne Henry ALERCHEK, INC. 203 ANDERSON ST. Portland, ME 04101 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-03 |
| Decision Date | 1986-04-22 |