The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Para-8.
| Device ID | K791228 |
| 510k Number | K791228 |
| Device Name: | PARA-8 |
| Classification | Mixture, Hematology Quality Control |
| Applicant | STRECK LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-02 |
| Decision Date | 1979-08-03 |