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 |