The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Seraquest Cmv Igg.
| Device ID | K954191 |
| 510k Number | K954191 |
| Device Name: | SERAQUEST CMV IGG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| 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 | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1996-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015198 | K954191 | 000 |
| 00816057020553 | K954191 | 000 |
| 00847865011198 | K954191 | 000 |
| 00847865011181 | K954191 | 000 |
| 00847865011174 | K954191 | 000 |
| 00847865011136 | K954191 | 000 |
| 00847865010726 | K954191 | 000 |