The following data is part of a premarket notification filed by Hitachi Chemical Diagnostics, Inc. with the FDA for Ap 72os Semi-automated Instrument.
| Device ID | K112910 |
| 510k Number | K112910 |
| Device Name: | AP 72OS SEMI-AUTOMATED INSTRUMENT |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE COURT Mountain View, CA 94043 |
| Contact | Donald Postel |
| Correspondent | Donald Postel HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE COURT Mountain View, CA 94043 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2012-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813382010211 | K112910 | 000 |