CHLAMYDIA (LGV-1)
FDA 510(k) clearance K894625 · decided 1989-08-15
Clearance details
- K-number
- K894625
- Device name
- CHLAMYDIA (LGV-1)
- Applicant
- Bion Ent., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-20
- Decision date
- 1989-08-15
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- LKI
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Park Ridge, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bion Ent.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (K914953) | Stellar Bio Systems, Inc. | 1992-02-19 |
| LUPUS(LE)-LATEX TEST (K905531) | Immco Diagnostics, Inc. | 1991-01-25 |
| BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE (K883776) | Btc Corp. | 1989-02-03 |
| MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES (K854615) | Serono Diagnostics, Inc. | 1986-01-28 |
| CULUTURE SET CHLAMYDIA ISOLATION AND (K830342) | Immulok, Inc. | 1983-05-04 |
Recalls involving this device
No recalls on record reference this clearance.