The following data is part of a premarket notification filed by Cambridge Bioscience Corp. with the FDA for Adenoclone(tm)-ifa, Adenovirus Antigen Test.
| Device ID | K873312 |
| 510k Number | K873312 |
| Device Name: | ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST |
| Classification | Antigens, Cf (including Cf Control), Adenovirus 1-33 |
| Applicant | CAMBRIDGE BIOSCIENCE CORP. 365 PLANTATION ST. Worcester, MA 01605 |
| Contact | Jack Cassorla |
| Correspondent | Jack Cassorla CAMBRIDGE BIOSCIENCE CORP. 365 PLANTATION ST. Worcester, MA 01605 |
| Product Code | GOD |
| CFR Regulation Number | 866.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-18 |
| Decision Date | 1988-02-24 |