The following data is part of a premarket notification filed by Sarstedt, Inc. with the FDA for Urine Monovette Boric Acid.
| Device ID | K024237 |
| 510k Number | K024237 |
| Device Name: | URINE MONOVETTE BORIC ACID |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | SARSTEDT, INC. 1025 ST. JAMES CHURCH RD. Newton, NC 28658 |
| Contact | Peter Rumswinkel |
| Correspondent | Peter Rumswinkel SARSTEDT, INC. 1025 ST. JAMES CHURCH RD. Newton, NC 28658 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-23 |
| Decision Date | 2003-04-14 |