The following data is part of a premarket notification filed by Alerchek, Inc. with the FDA for Flipscreen Qat.
Device ID | K874802 |
510k Number | K874802 |
Device Name: | FLIPSCREEN QAT |
Classification | System, Test, Radioallergosorbent (rast) Immunological |
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 | DHB |
CFR Regulation Number | 866.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-23 |
Decision Date | 1988-02-17 |