Chlamydia Trachomatis Antigen Test
FDA 510(k) K941714 · Neogenex
510(k) numberK941714
Submission
- Device name
- Chlamydia Trachomatis Antigen Test
- Applicant
- Neogenex
Everett, WA, US - Received
- March 23, 1994
- Decision date
- July 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LJP – Antiserum, Fluorescent, Chlamydia Trachomatis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3120
- Specialty
- Microbiology
Other 510(k)s with product code LJP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063675 | Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation KitLJP · Traditional | Diagnostic Hybrids, Inc. | 09/24/2007SE |
| K901243 | Chlamydia-Cel Immunofluorenscence (If) TestLJP · Traditional | Cel Labs Pty, Ltd. | 05/21/1990SE |
| K900870 | Pathodx Chlamydia Trachomatis Direct Specimen TestLJP · Traditional | Diagnostic Products Corp. | 04/16/1990SE |
| K895839 | Pathodx Chlamydia Culture Confirmation PKCC1LJP · Traditional | Diagnostic Products Corp. | 02/01/1990SE |
| K883352 | Fluorescein Conjugated Anti-Chlamydia Mono AntiLJP · Traditional | Whittaker Bioproducts, Inc. | 10/06/1988SE |
| K881500 | Ortho* Chlamydia Direct Detection (Fa) TestLJP · Traditional | Ortho Diagnostic Systems, Inc. | 04/27/1988SE |
| K880031 | Pathfinder(Tm) Direct Detection Sys C. TrachomatisLJP · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 03/17/1988SE |
| K872744 | Modified Chlamyset AntigenLJP · Traditional | Orion Corp. | 09/22/1987SE |
| K872903 | Microtrak Chlamydia Tracho. Test - Methanol Fixat.LJP · Traditional | Syva Co. | 08/06/1987SE |
| K870946 | Monabrite Chlamydia Trachomatis Dir. Specimen TestLJP · Traditional | Serono Diagnostics, Inc. | 04/29/1987SE |
More from Serono Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K965047 | Mink Lung Cell CultureKIR · Traditional | 02/04/1997SE |
| K960909 | H292 Cell CultureKIR · Traditional | 05/30/1996SE |
| K943891 | RD Culture CellKIR · Traditional | 11/28/1994SE |
| K943890 | WI38 Cell CultureKIR · Traditional | 11/28/1994SE |
| K943889 | Vero Cell CultureKIR · Traditional | 11/28/1994SE |
| K943888 | MDCK Cell CultureKIR · Traditional | 11/28/1994SE |
| K943887 | Human Newborn Foreskin Cell CultureKIR · Traditional | 11/28/1994SE |
| K943886 | BGM Cell CultureKIR · Traditional | 11/28/1994SE |
| K943885 | Primary Rabbit Kidney Cell CultureKIR · Traditional | 11/28/1994SE |
| K943884 | Primary Monkey Kidney Cell CultureKIR · Traditional | 11/28/1994SE |
Questions and answers
When was Chlamydia Trachomatis Antigen Test cleared by the FDA?
Chlamydia Trachomatis Antigen Test (K941714) received a 510(k) decision of Substantially Equivalent on July 18, 1994, 117 days after the submission was received.
What is the product code of K941714?
The FDA product code is LJP – Antiserum, Fluorescent, Chlamydia Trachomatis, a Class I (low risk) device regulated under 21 CFR 866.3120.