The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Dimension(r) Lactic Acid Method.
| Device ID | K914508 |
| 510k Number | K914508 |
| Device Name: | DIMENSION(R) LACTIC ACID METHOD |
| Classification | Acid, Lactic, Enzymatic Method |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
| Contact | Robert B Taylor |
| Correspondent | Robert B Taylor E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
| Product Code | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-09 |
| Decision Date | 1991-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005398 | K914508 | 000 |