The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventrezyme Vast Immuno-peroxidase Assay.
| Device ID | K880547 |
| 510k Number | K880547 |
| Device Name: | VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland, ME 04103 |
| Contact | James W Champlin |
| Correspondent | James W Champlin 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 | 1988-02-09 |
| Decision Date | 1988-03-25 |