The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Nitroprusside Test Procedure.
Device ID | K810514 |
510k Number | K810514 |
Device Name: | SANDARE NITROPRUSSIDE TEST PROCEDURE |
Classification | Nitroprusside Reaction (qualitative, Urine), Cystine |
Applicant | SANDARE CHEMICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JLC |
CFR Regulation Number | 862.1240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-25 |
Decision Date | 1981-03-04 |