The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Piccolo(tm).
| Device ID | K942782 |
| 510k Number | K942782 |
| Device Name: | PICCOLO(TM) |
| Classification | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Applicant | ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Contact | Rodger J Richeal |
| Correspondent | Rodger J Richeal ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Product Code | JJG |
| Subsequent Product Code | CDN |
| Subsequent Product Code | CEJ |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CJW |
| CFR Regulation Number | 862.2140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-13 |
| Decision Date | 1995-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EABA40000331 | K942782 | 000 |