The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Pathodx Respiratory Virus Panel Model Pkrp1.
| Device ID | K983336 |
| 510k Number | K983336 |
| Device Name: | PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine |
| Correspondent | Edward M Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | LKT |
| Subsequent Product Code | GNX |
| Subsequent Product Code | GNY |
| Subsequent Product Code | GQS |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-23 |
| Decision Date | 1999-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080501772 | K983336 | 000 |
| 05056080501697 | K983336 | 000 |
| 05056080501703 | K983336 | 000 |
| 05056080501710 | K983336 | 000 |
| 05056080501727 | K983336 | 000 |
| 05056080501734 | K983336 | 000 |
| 05056080501741 | K983336 | 000 |
| 05056080501758 | K983336 | 000 |
| 05056080501765 | K983336 | 000 |
| 05056080501680 | K983336 | 000 |