The following data is part of a premarket notification filed by Triangle Biomedical Sciences, Inc. with the FDA for Micro21 With Wbc Estimate.
Device ID | K973050 |
510k Number | K973050 |
Device Name: | MICRO21 WITH WBC ESTIMATE |
Classification | Device, Automated Cell-locating |
Applicant | TRIANGLE BIOMEDICAL SCIENCES, INC. 4360 NORTHLAKE BLVD., #100 Palm Beach Gardens, FL 33410 |
Contact | R. Otto Stellner |
Correspondent | R. Otto Stellner TRIANGLE BIOMEDICAL SCIENCES, INC. 4360 NORTHLAKE BLVD., #100 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 | 1997-08-15 |
Decision Date | 1997-11-07 |
Summary: | summary |