510(k) K894625
- Device
- CHLAMYDIA (LGV-1)
- Applicant
- BION ENT., LTD.
- 510(k) number
- K894625
- Product code
- LKI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-08-15
- Date received
- 1989-07-20
- Regulation
- 866.3120
- Classification name
- Antisera, Fluorescent, Chlamydia Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUDY MCCORMACK
- Address
- 674 Busse Hwy. Park Ridge IL US 60068 60068
FDA Registration Numbers#
- 2023365
- 2242436
- 1419968
- 3004973408
- 1524213
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LKI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914953 | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY | Stellar Bio Systems, Inc. | 1992-02-19 |
| K905531 | LUPUS(LE)-LATEX TEST | Immco Diagnostics, Inc. | 1991-01-25 |
| K883776 | BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE | Btc Corp. | 1989-02-03 |
| K854615 | MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES | Serono Diagnostics, Inc. | 1986-01-28 |
| K830342 | CULUTURE SET CHLAMYDIA ISOLATION AND | Immulok, Inc. | 1983-05-04 |
Legacy Summary#
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FDA Review#
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