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 |