The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack Hcg Immunoassay.
Device ID | K072264 |
510k Number | K072264 |
Device Name: | FASTPACK HCG IMMUNOASSAY |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92011 |
Contact | Michael S Poirier |
Correspondent | Michael S Poirier Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92011 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-15 |
Decision Date | 2007-12-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816467020112 | K072264 | 000 |
00816467020105 | K072264 | 000 |
10816467020126 | K072264 | 000 |