The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Prolex (streptoccal Grouping Latex Kit).
| Device ID | K934383 |
| 510k Number | K934383 |
| Device Name: | PROLEX (STREPTOCCAL GROUPING LATEX KIT) |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | PRO-LAB, INC. 20 MURAL ST., #4 Richmond Hill, Ontario, CA L4b 1k3 |
| Contact | Robert Rae |
| Correspondent | Robert Rae PRO-LAB, INC. 20 MURAL ST., #4 Richmond Hill, Ontario, CA L4b 1k3 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-09 |
| Decision Date | 1995-01-27 |