The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Antinuclear Antibody (ana) Test (mouse Liver Sect).
Device ID | K883949 |
510k Number | K883949 |
Device Name: | ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) |
Classification | Antinuclear Antibody, Antigen, Control |
Applicant | IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
Contact | Russell Nisengard |
Correspondent | Russell Nisengard IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
Product Code | LKJ |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-19 |
Decision Date | 1988-10-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00845714004339 | K883949 | 000 |
00845714004322 | K883949 | 000 |
00845714003448 | K883949 | 000 |
00845714003011 | K883949 | 000 |