The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Polymedco Oc Light Fobt Test.
| Device ID | K041297 |
| 510k Number | K041297 |
| Device Name: | POLYMEDCO OC LIGHT FOBT TEST |
| Classification | Reagent, Occult Blood |
| Applicant | POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | Helen Landicho |
| Correspondent | Helen Landicho POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-14 |
| Decision Date | 2004-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816917022802 | K041297 | 000 |
| 00816917021539 | K041297 | 000 |
| 00855574005094 | K041297 | 000 |
| 00855574005070 | K041297 | 000 |
| 00855574005063 | K041297 | 000 |
| 00855574005056 | K041297 | 000 |
| 10304040102524 | K041297 | 000 |