The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Spotchem Ii Chemistry Basic 1 And Chemistry Basic 2 Tests.
Device ID | K053401 |
510k Number | K053401 |
Device Name: | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS |
Classification | Cresolphthalein Complexone, Calcium |
Applicant | ARKRAY, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
Contact | Helen Landicho |
Correspondent | Helen Landicho ARKRAY, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
Product Code | CIC |
Subsequent Product Code | CEK |
Subsequent Product Code | CGA |
Subsequent Product Code | CGX |
Subsequent Product Code | CIX |
Subsequent Product Code | JGZ |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-06 |
Decision Date | 2006-03-24 |