The following data is part of a premarket notification filed by Zeptometrix with the FDA for Nattrol Bd Max Vaginal Panel External Controls.
| Device ID | K201403 |
| 510k Number | K201403 |
| Device Name: | NATtrol BD MAX Vaginal Panel External Controls |
| Classification | Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
| Applicant | Zeptometrix 878 Main Street Buffalo, NY 14202 |
| Contact | Shawn Smith |
| Correspondent | Michael Smith MDC Associates Inc. 180 Cabot Street Beverly, MA 01915 |
| Product Code | PMN |
| CFR Regulation Number | 866.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-28 |
| Decision Date | 2022-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 01220000260252 | K201403 | 000 |
| 01220000260245 | K201403 | 000 |
| 01220000260238 | K201403 | 000 |