The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Total Protein Test (tpro) Item Number: Xxxxx/r1. R2.
Device ID | K950234 |
510k Number | K950234 |
Device Name: | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 |
Classification | Biuret (colorimetric), Total Protein |
Applicant | EMD CHEMICALS INC. DIV. OF EM INDUSTRIES INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
Contact | Carol Faulkner |
Correspondent | Carol Faulkner EMD CHEMICALS INC. DIV. OF EM INDUSTRIES INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
Product Code | CEK |
CFR Regulation Number | 862.1635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-13 |
Decision Date | 1995-06-14 |