The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunodot(r) Ena/dna Autoimmunity Screening Panel.
Device ID | K924843 |
510k Number | K924843 |
Device Name: | IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL |
Classification | Extractable Antinuclear Antibody, Antigen And Control |
Applicant | GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
Contact | Bryan L Kiehl |
Correspondent | Bryan L Kiehl GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
Product Code | LLL |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-28 |
Decision Date | 1992-12-01 |