COLONCARE
Reagent, Occult Blood
CARE PRODUCTS, INC.
The following data is part of a premarket notification filed by Care Products, Inc. with the FDA for Coloncare.
Pre-market Notification Details
| Device ID | K030216 |
| 510k Number | K030216 |
| Device Name: | COLONCARE |
| Classification | Reagent, Occult Blood |
| Applicant | CARE PRODUCTS, INC. 231 BANK STREET SUITE 203 Waterbury, CT 06702 |
| Contact | Hubert Pototschnig |
| Correspondent | Hubert Pototschnig CARE PRODUCTS, INC. 231 BANK STREET SUITE 203 Waterbury, CT 06702 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-04-02 |
Trademark Results [COLONCARE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COLONCARE 78304536 not registered Dead/Abandoned |
Scheuringer, Kim, J 2003-09-24 |
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