The following data is part of a premarket notification filed by N-dia, Inc. with the FDA for Amnisure Fetal Membranes Rupture Test Model Fmrt1.
| Device ID | K030849 |
| 510k Number | K030849 |
| Device Name: | AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | N-DIA, INC. 30 E. 20TH ST., STE. 501 New York, NY 10003 |
| Contact | Michael Friedman |
| Correspondent | Michael Friedman N-DIA, INC. 30 E. 20TH ST., STE. 501 New York, NY 10003 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-17 |
| Decision Date | 2004-02-02 |