The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Auraflex Ck-mb 200test Pack, Calibrator Pack.
| Device ID | K951638 |
| 510k Number | K951638 |
| Device Name: | AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | C. D Kafader, Ii |
| Correspondent | C. D Kafader, Ii ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-10 |
| Decision Date | 1995-05-02 |