The following data is part of a premarket notification filed by Novo Nordisk Diagnostics, Ltd. with the FDA for Ideia(tm) Chlamydia, Modification.
| Device ID | K911430 |
| 510k Number | K911430 |
| Device Name: | IDEIA(TM) CHLAMYDIA, MODIFICATION |
| Classification | Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae |
| Applicant | NOVO NORDISK DIAGNOSTICS, LTD. DIRAC HOUSE, ST. JOHN'S INNOVATION PARK, COWLEY RD. Cambridge Cb4 4ws England, GB |
| Contact | Stephen A Abbott |
| Correspondent | Stephen A Abbott NOVO NORDISK DIAGNOSTICS, LTD. DIRAC HOUSE, ST. JOHN'S INNOVATION PARK, COWLEY RD. Cambridge Cb4 4ws England, GB |
| Product Code | LIC |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-28 |
| Decision Date | 1991-08-07 |