The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack Cea Calibration Verification Test Set.
| Device ID | K924857 |
| 510k Number | K924857 |
| Device Name: | AIA-PACK CEA CALIBRATION VERIFICATION TEST SET |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | TOSOH MEDICS, INC. 800 A GATEWAY BLVD. South San Francisco, CA 94080 |
| Contact | Richard M Crompton |
| Correspondent | Richard M Crompton TOSOH MEDICS, INC. 800 A GATEWAY BLVD. South San Francisco, CA 94080 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-28 |
| Decision Date | 1993-03-18 |