The following data is part of a premarket notification filed by Hitachi Chemical Diagnostics, Inc. with the FDA for Cla Allergen-specific Ige Assay-latex Allergen (k82).
| Device ID | K030590 |
| 510k Number | K030590 |
| Device Name: | CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE CT. Mountain View, CA 94043 |
| Contact | Mary Ann Du Brock |
| Correspondent | Mary Ann Du Brock HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE CT. Mountain View, CA 94043 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-25 |
| Decision Date | 2003-03-21 |
| Summary: | summary |