The following data is part of a premarket notification filed by Intercare Diagnostics, Inc. with the FDA for Chlamydia Tissue Culture Confirmation Test (eia).
| Device ID | K862948 |
| 510k Number | K862948 |
| Device Name: | CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | INTERCARE DIAGNOSTICS, INC. 1440 4TH ST. Berkeley, CA 94710 |
| Contact | Stan Tsing |
| Correspondent | Stan Tsing INTERCARE DIAGNOSTICS, INC. 1440 4TH ST. Berkeley, CA 94710 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-05 |
| Decision Date | 1986-10-17 |