The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Alt Microwell Test System.
| Device ID | K941192 |
| 510k Number | K941192 |
| Device Name: | ORTHO ALT MICROWELL TEST SYSTEM |
| Classification | Hydrazone Colorimetry, Alt/sgpt |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Contact | Kim W Gray |
| Correspondent | Kim W Gray ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Product Code | CKD |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1995-05-16 |