The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Seraquest Hsv Igg.
| Device ID | K963282 |
| 510k Number | K963282 |
| Device Name: | SERAQUEST HSV IGG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | QUEST INTL., INC. 1938 N.E. 148TH TERR. North Miami, FL 33181 |
| Contact | Robert A Cort |
| Correspondent | Robert A Cort QUEST INTL., INC. 1938 N.E. 148TH TERR. North Miami, FL 33181 |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-21 |
| Decision Date | 1997-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015211 | K963282 | 000 |
| 00816057020577 | K963282 | 000 |
| 00847865010740 | K963282 | 000 |