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 |