The following data is part of a premarket notification filed by P-l Biochemicals, Inc. with the FDA for Tobram E.r.a. Tm.
Device ID | K800517 |
510k Number | K800517 |
Device Name: | TOBRAM E.R.A. TM |
Classification | Radioimmunoassay, Amikacin |
Applicant | P-L BIOCHEMICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KLQ |
CFR Regulation Number | 862.3035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-05 |
Decision Date | 1980-03-20 |