The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack Ige Calibration Verification Test Set.
| Device ID | K924859 |
| 510k Number | K924859 |
| Device Name: | AIA-PACK IGE CALIBRATION VERIFICATION TEST SET |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D Foster City, CA 94404 |
| Contact | Richard M Crompton |
| Correspondent | Richard M Crompton TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D Foster City, CA 94404 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-28 |
| Decision Date | 1993-05-14 |