The following data is part of a premarket notification filed by Quest International, Inc with the FDA for Seraquest Herpes Type 1 Specific Igg.
| Device ID | K162276 |
| 510k Number | K162276 |
| Device Name: | SeraQuest Herpes Type 1 Specific IgG |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Applicant | QUEST INTERNATIONAL, INC 8127 NW 29TH STREET Miami, FL 33122 |
| Contact | David J. Kiefer |
| Correspondent | David J. Kiefer QUEST INTERNATIONAL, INC 8127 NW 29TH STREET Miami, FL 33122 |
| Product Code | MXJ |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-12 |
| Decision Date | 2016-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610522051076 | K162276 | 000 |