The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Piccolo Phosphorus Test System.
Device ID | K022312 |
510k Number | K022312 |
Device Name: | PICCOLO PHOSPHORUS TEST SYSTEM |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | ABAXIS, INC. 3240 WHIPPLE RD. Union City, CA 94587 |
Contact | Robert Milder |
Correspondent | Robert Milder ABAXIS, INC. 3240 WHIPPLE RD. Union City, CA 94587 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-17 |
Decision Date | 2002-09-05 |
Summary: | summary |