The following data is part of a premarket notification filed by Cambridge Biotech Corp. with the FDA for Cytoclone A & B Eia.
| Device ID | K911958 |
| 510k Number | K911958 |
| Device Name: | CYTOCLONE A & B EIA |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | CAMBRIDGE BIOTECH CORP. 365 PLANTATION ST. Worcester, MA 01605 |
| Contact | Jack Cassorla |
| Correspondent | Jack Cassorla CAMBRIDGE BIOTECH CORP. 365 PLANTATION ST. Worcester, MA 01605 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-03 |
| Decision Date | 1991-07-30 |