The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Total Protein Test (tpro) Item Xxxxx/r1. R2.
| Device ID | K950128 |
| 510k Number | K950128 |
| Device Name: | TOTAL PROTEIN TEST (TPRO) ITEM 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 | 1995-01-12 |
| Decision Date | 1995-05-15 |