The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Koagulab Cts Chromogrnic Testing System.
| Device ID | K914188 |
| 510k Number | K914188 |
| Device Name: | KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Contact | Patrick A Roche |
| Correspondent | Patrick A Roche ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-18 |
| Decision Date | 1992-08-26 |