The following data is part of a premarket notification filed by In Vitro Technologies, Inc. with the FDA for 866.5750 Radioallergosorbent Immunlogical Test Sys.
| Device ID | K914685 |
| 510k Number | K914685 |
| Device Name: | 866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | IN VITRO TECHNOLOGIES, INC. 2100 RD TO SIX FLAGS, EAST P.O. BOX 202003 Arlington, TX 76011 |
| Contact | Kenneth Kelly |
| Correspondent | Kenneth Kelly IN VITRO TECHNOLOGIES, INC. 2100 RD TO SIX FLAGS, EAST P.O. BOX 202003 Arlington, TX 76011 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-18 |
| Decision Date | 1992-09-14 |