The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Colorpac Toxin A.
| Device ID | K980185 |
| 510k Number | K980185 |
| Device Name: | COLORPAC TOXIN A |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Contact | Colleen A Rohrbeck |
| Correspondent | Colleen A Rohrbeck BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-20 |
| Decision Date | 1998-07-17 |
| Summary: | summary |