HEMA-SCREEN
Reagent, Occult Blood
IMMUNOSTICS CO., INC.
The following data is part of a premarket notification filed by Immunostics Co., Inc. with the FDA for Hema-screen.
Pre-market Notification Details
| Device ID | K902360 |
| 510k Number | K902360 |
| Device Name: | HEMA-SCREEN |
| Classification | Reagent, Occult Blood |
| Applicant | IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | Kenneth Kupits |
| Correspondent | Kenneth Kupits IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-29 |
| Decision Date | 1990-07-27 |
Trademark Results [HEMA-SCREEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMA-SCREEN 76167666 2506476 Live/Registered |
STANBIO LABORATORY 2000-11-20 |
 HEMA-SCREEN 75392219 not registered Dead/Abandoned |
IMMUNOSTICS, INC. 1997-11-18 |
 HEMA-SCREEN 74053099 not registered Dead/Abandoned |
IMMUNOSTICS CO., INC. 1990-04-26 |
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