HEMOPLUS
Reagent, Occult Blood
SARSTEDT, INC.
The following data is part of a premarket notification filed by Sarstedt, Inc. with the FDA for Hemoplus.
Pre-market Notification Details
| Device ID | K913622 |
| 510k Number | K913622 |
| Device Name: | HEMOPLUS |
| Classification | Reagent, Occult Blood |
| Applicant | SARSTEDT, INC. P.O. BOX 468, RT 2, ST. JAMES CHURCH RD. Newton, NC 28658 -0468 |
| Contact | James E Yancsek |
| Correspondent | James E Yancsek SARSTEDT, INC. P.O. BOX 468, RT 2, ST. JAMES CHURCH RD. Newton, NC 28658 -0468 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-14 |
| Decision Date | 1992-01-31 |
Trademark Results [HEMOPLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOPLUS 86949241 not registered Dead/Abandoned |
Perlei Medical, Inc. 2016-03-22 |
 HEMOPLUS 77806000 3767235 Dead/Cancelled |
Cooper, Josefa 2009-08-17 |
 HEMOPLUS 73681419 not registered Dead/Abandoned |
CEDERROTH NORDIC AB 1995-05-11 |
 HEMOPLUS 73524064 1393647 Dead/Cancelled |
WALTER SARSTEDT KUNSTSTOFF-SPRITZGUSSWERK 1985-02-25 |
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