The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Piccolo Chloride Test System.
| Device ID | K010670 |
| 510k Number | K010670 |
| Device Name: | PICCOLO CHLORIDE TEST SYSTEM |
| Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
| Applicant | ABAXIS, INC. 3240 WHIPPLE RD. Union City, CA 94587 |
| Contact | Amy Levin |
| Correspondent | Amy Levin ABAXIS, INC. 3240 WHIPPLE RD. Union City, CA 94587 |
| Product Code | CHJ |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-06 |
| Decision Date | 2001-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EABA40000371 | K010670 | 000 |
| EABA40000341 | K010670 | 000 |
| EABA40000311 | K010670 | 000 |
| EABA40000281 | K010670 | 000 |
| EABA40000271 | K010670 | 000 |
| EABA40000241 | K010670 | 000 |
| EABA40000231 | K010670 | 000 |
| EABA40000221 | K010670 | 000 |