The following data is part of a premarket notification filed by Quest International, Inc. with the FDA for Seraquest Hsv Type 2 Specific Igg.
| Device ID | K152353 |
| 510k Number | K152353 |
| Device Name: | SeraQuest HSV Type 2 Specific IgG |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| 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 | MYF |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-20 |
| Decision Date | 2016-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610522051236 | K152353 | 000 |