The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Polytiter System.
| Device ID | K012163 |
| 510k Number | K012163 |
| Device Name: | POLYTITER SYSTEM |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | Hellen Landicho |
| Correspondent | Hellen Landicho POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-11 |
| Decision Date | 2001-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855574005360 | K012163 | 000 |