The following data is part of a premarket notification filed by Triangle Biomedical Sciences, Inc. with the FDA for Micro21 With Urine Sediment Analysis.
| Device ID | K982301 |
| 510k Number | K982301 |
| Device Name: | MICRO21 WITH URINE SEDIMENT ANALYSIS |
| Classification | Device, Automated Cell-locating |
| Applicant | TRIANGLE BIOMEDICAL SCIENCES, INC. 4360 NORTHLAKE BLVD., #214 Palm Beach Gardens, FL 33410 |
| Contact | R Otto Stellner |
| Correspondent | R Otto Stellner TRIANGLE BIOMEDICAL SCIENCES, INC. 4360 NORTHLAKE BLVD., #214 Palm Beach Gardens, FL 33410 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-01 |
| Decision Date | 1998-08-07 |
| Summary: | summary |