The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunodot Autoimmune Screening Panel 1.
Device ID | K896347 |
510k Number | K896347 |
Device Name: | IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 |
Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
Applicant | GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
Contact | Kiehl, Phd |
Correspondent | Kiehl, Phd GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
Product Code | LJM |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-03 |
Decision Date | 1989-12-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613745051895 | K896347 | 000 |
00613745051253 | K896347 | 000 |
00613745039206 | K896347 | 000 |
00613745039183 | K896347 | 000 |