510(k) K914953
- Device
- IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY
- Applicant
- STELLAR BIO SYSTEMS, INC.
- 510(k) number
- K914953
- Product code
- LKI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-02-19
- Date received
- 1991-11-05
- Regulation
- 866.3120
- Classification name
- Antisera, Fluorescent, Chlamydia Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN M.BREWER
- Address
- 9075 Guilford Rd. Columbia MD US 21046 21046
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 |
|---|---|---|---|
| K905531 | LUPUS(LE)-LATEX TEST | Immco Diagnostics, Inc. | 1991-01-25 |
| K894625 | CHLAMYDIA (LGV-1) | Bion Ent., Ltd. | 1989-08-15 |
| 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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