The following data is part of a premarket notification filed by Potomac Medical System with the FDA for Metachrome.
| Device ID | K851174 |
| 510k Number | K851174 |
| Device Name: | METACHROME |
| Classification | Analyzer, Chromosome, Automated |
| Applicant | POTOMAC MEDICAL SYSTEM P.O. BOX 4212 SILVER SPRING, MD 20904 |
| Contact | ROBERT S LEDLEY |
| Correspondent | ROBERT S LEDLEY POTOMAC MEDICAL SYSTEM P.O. BOX 4212 SILVER SPRING, MD 20904 |
| Product Code | LNJ |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-25 |
| Decision Date | 1985-05-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() METACHROME 87095968 5095596 Live/Registered |
TELEDYNE DIGITAL IMAGING US, INC. 2016-07-07 |
![]() METACHROME 74335167 1785177 Dead/Cancelled |
AMRION, INC. 1992-11-27 |
![]() METACHROME 73749110 1561690 Dead/Cancelled |
PHOTOMETRICS LTD. 1988-08-29 |
![]() METACHROME 73709827 1541282 Dead/Cancelled |
AN-CON GENETICS, INC. 1988-02-08 |
![]() METACHROME 73483144 not registered Dead/Abandoned |
NATIONAL BIOMEDICAL RESEARCH FOUNDATION, INC. 1984-06-01 |