The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Pathodx Respiratory Syncytial Virus (rsv).
| Device ID | K943317 |
| 510k Number | K943317 |
| Device Name: | PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Kenneth B Asarch |
| Correspondent | Kenneth B Asarch DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-11 |
| Decision Date | 1994-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080501796 | K943317 | 000 |
| 05056080501789 | K943317 | 000 |