The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Sigma Cx-3 Calibration Standard Level 1.
Device ID | K933702 |
510k Number | K933702 |
Device Name: | SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
Contact | William R Gilbert |
Correspondent | William R Gilbert SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
Product Code | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-29 |
Decision Date | 1993-10-08 |