HEMATACHEK
Control, Hematocrit
RICHMOND DIAGNOSTICS, INC.
The following data is part of a premarket notification filed by Richmond Diagnostics, Inc. with the FDA for Hematachek.
Pre-market Notification Details
| Device ID | K964452 |
| 510k Number | K964452 |
| Device Name: | HEMATACHEK |
| Classification | Control, Hematocrit |
| Applicant | RICHMOND DIAGNOSTICS, INC. 100 JERSEY AVE., SUITE 202A, BLDG. B New Brunswick, NJ 08901 |
| Contact | Joseph P Pineno |
| Correspondent | Joseph P Pineno RICHMOND DIAGNOSTICS, INC. 100 JERSEY AVE., SUITE 202A, BLDG. B New Brunswick, NJ 08901 |
| Product Code | GLK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-06 |
| Decision Date | 1997-02-20 |
Trademark Results [HEMATACHEK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMATACHEK 76114313 2479977 Live/Registered |
SEPARATION TECHNOLOGY, INC. 2000-08-22 |
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