The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Specific Ige Eia-turbo Assay.
| Device ID | K914554 |
| 510k Number | K914554 |
| Device Name: | SPECIFIC IGE EIA-TURBO ASSAY |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland, ME 04103 |
| Contact | Tom Foley |
| Correspondent | Tom Foley VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland, ME 04103 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-11 |
| Decision Date | 1992-03-13 |