The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventrescreen Strep A Test.
| Device ID | K842239 |
| 510k Number | K842239 |
| Device Name: | VENTRESCREEN STREP A TEST |
| Classification | Antisera, All Types, Streptococcus Pneumoniae |
| Applicant | VENTREX LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GWC |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-05 |
| Decision Date | 1984-07-02 |