The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Fast 340 Phosphorus Procedure.
Device ID | K812670 |
510k Number | K812670 |
Device Name: | SANDARE FAST 340 PHOSPHORUS PROCEDURE |
Classification | 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase |
Applicant | SANDARE CHEMICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CED |
CFR Regulation Number | 862.1520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-09-21 |
Decision Date | 1981-10-02 |