The following data is part of a premarket notification filed by Triangle Biomedical Sciences, Inc. with the FDA for Micro21 With Ndna.
| Device ID | K964165 |
| 510k Number | K964165 |
| Device Name: | MICRO21 WITH NDNA |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | TRIANGLE BIOMEDICAL SCIENCES, INC. 4360 NORTHLAKE BLVD. SUITE 214 Palm Beach Gardens, FL 33410 |
| Contact | R. Otto Stellner |
| Correspondent | R. Otto Stellner TRIANGLE BIOMEDICAL SCIENCES, INC. 4360 NORTHLAKE BLVD. SUITE 214 Palm Beach Gardens, FL 33410 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-17 |
| Decision Date | 1997-01-03 |
| Summary: | summary |