The following data is part of a premarket notification filed by Biotecx Laboratories, Inc. with the FDA for Hpl Ria Kit.
| Device ID | K863188 |
| 510k Number | K863188 |
| Device Name: | HPL RIA KIT |
| Classification | Ninhydrin, Nitrogen (amino-nitrogen) |
| Applicant | BIOTECX LABORATORIES, INC. P.O. BOX 1421 Friendswood, TX 77546 |
| Contact | Mehra, Ph.d. |
| Correspondent | Mehra, Ph.d. BIOTECX LABORATORIES, INC. P.O. BOX 1421 Friendswood, TX 77546 |
| Product Code | JMX |
| CFR Regulation Number | 862.1515 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-19 |
| Decision Date | 1986-09-25 |