The following data is part of a premarket notification filed by Novo Nordisk Diagnostics, Ltd. with the FDA for Add'l Claimed Intended Use For Ideia(tm) Chlamydia.
| Device ID | K901972 |
| 510k Number | K901972 |
| Device Name: | ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | NOVO NORDISK DIAGNOSTICS, LTD. DIRAC HOUSE, ST. JOHN'S INNOVATION PARK, COWLEY RD. Cambridge Cb4 4ws England, GB |
| Contact | R Abbott,phd |
| Correspondent | R Abbott,phd NOVO NORDISK DIAGNOSTICS, LTD. DIRAC HOUSE, ST. JOHN'S INNOVATION PARK, COWLEY RD. Cambridge Cb4 4ws England, GB |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-01 |
| Decision Date | 1990-09-05 |