The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Total Iron In Serum.
Device ID | K782160 |
510k Number | K782160 |
Device Name: | TOTAL IRON IN SERUM |
Classification | Photometric Method, Iron (non-heme) |
Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JIY |
CFR Regulation Number | 862.1410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-21 |
Decision Date | 1979-01-26 |