The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Urea Nitrogen(bun), Colorimetric Method.
Device ID | K864742 |
510k Number | K864742 |
Device Name: | UREA NITROGEN(BUN), COLORIMETRIC METHOD |
Classification | Berthelot Indophenol, Urea Nitrogen |
Applicant | TECH-CO, INC. 4378 REILLY Troy, MI 48098 |
Contact | Happy Chen |
Correspondent | Happy Chen TECH-CO, INC. 4378 REILLY Troy, MI 48098 |
Product Code | CDL |
CFR Regulation Number | 862.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-04 |
Decision Date | 1987-01-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10673486001273 | K864742 | 000 |
10673486001266 | K864742 | 000 |