The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Ferritin Elisa Model Bc-1025.
Device ID | K992517 |
510k Number | K992517 |
Device Name: | BIOCHECK FERRITIN ELISA MODEL BC-1025 |
Classification | Ferritin, Antigen, Antiserum, Control |
Applicant | BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
Contact | Robin Hellen |
Correspondent | Robin Hellen BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
Product Code | DBF |
CFR Regulation Number | 866.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-28 |
Decision Date | 1999-09-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00811727013323 | K992517 | 000 |
B24225FERHUE010 | K992517 | 000 |
00840239018724 | K992517 | 000 |
00850392007251 | K992517 | 000 |