The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Culturette Brand Rapid Latex Test Clostridium Toxi.
| Device ID | K852044 |
| 510k Number | K852044 |
| Device Name: | CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Contact | William H Guinty |
| Correspondent | William H Guinty MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-09 |
| Decision Date | 1985-07-19 |