The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Lancer L-ina Human Reference Serum.
Device ID | K792013 |
510k Number | K792013 |
Device Name: | LANCER L-INA HUMAN REFERENCE SERUM |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-05 |
Decision Date | 1979-11-13 |