The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Dimension Amylase Method.
| Device ID | K942640 |
| 510k Number | K942640 |
| Device Name: | DUPONT DIMENSION AMYLASE METHOD |
| Classification | Catalytic Methods, Amylase |
| Applicant | DUPONT MEDICAL PRODUCTS P.O. BOX 80022 BMP 22/1158 Wilmington, DE 19880 |
| Contact | Cathy P Craft |
| Correspondent | Cathy P Craft DUPONT MEDICAL PRODUCTS P.O. BOX 80022 BMP 22/1158 Wilmington, DE 19880 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-03 |
| Decision Date | 1994-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005404 | K942640 | 000 |