The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Latex-specific Ige.
| Device ID | K963245 |
| 510k Number | K963245 |
| Device Name: | IMMULITE LATEX-SPECIFIC IGE |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| 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 | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-19 |
| Decision Date | 1996-11-18 |
| Summary: | summary |