LUPUS(LE)-LATEX TEST
FDA 510(k) clearance K905531 · decided 1991-01-25
Clearance details
- K-number
- K905531
- Device name
- LUPUS(LE)-LATEX TEST
- Applicant
- Immco Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-10
- Decision date
- 1991-01-25
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- LKI
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Buffalo, NY, US
- Third-party review
- No
- Expedited review
- No
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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 |
| CHLAMYDIA (LGV-1) (K894625) | Bion Ent., Ltd. | 1989-08-15 |
| 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.