The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Visible-chlamydia(tm) Test System.
| Device ID | K862638 |
| 510k Number | K862638 |
| Device Name: | VISIBLE-CHLAMYDIA(TM) TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Contact | Loren F Hazelwood |
| Correspondent | Loren F Hazelwood ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-10 |
| Decision Date | 1986-08-26 |