The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Amniotest(tm).
| Device ID | K914419 |
| 510k Number | K914419 |
| Device Name: | AMNIOTEST(TM) |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | PRO-LAB, INC. 76 GLENGARRY AVENUE TORONTO Ontario Canada M5m 1c9, CA |
| Contact | Joachim Sparkuhl |
| Correspondent | Robert J Rae Pro-lab Diagnostics USA 21 Cypress Blvd., Suite 1070 Round Rock, TX 78665 -1034 |
| Product Code | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-03 |
| Decision Date | 1993-09-01 |