LJP — Antiserum, Fluorescent, Chlamydia Trachomatis Class I
FDA Device Classification
Classification Details
- Product Code
- LJP
- Device Class
- Class I
- Regulation Number
- 866.3120
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K063675 | diagnostic hybrids | DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT | September 24, 2007 |
| K941714 | neogenex | CHLAMYDIA TRACHOMATIS ANTIGEN TEST | July 18, 1994 |
| K901243 | cel labs pty | CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST | May 21, 1990 |
| K900870 | diagnostic products | PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST | April 16, 1990 |
| K895839 | diagnostic products | PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 | February 1, 1990 |
| K883352 | whittaker bioproducts | FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI | October 6, 1988 |
| K881500 | ortho diagnostic systems | ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST | April 27, 1988 |
| K880031 | kallestad diag, a div. of erbamont | PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS | March 17, 1988 |
| K872744 | orion | MODIFIED CHLAMYSET ANTIGEN | September 22, 1987 |
| K872903 | syva | MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. | August 6, 1987 |
| K864128 | diagnostic technology | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | April 29, 1987 |
| K870946 | serono diagnostics | MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST | April 29, 1987 |
| K871278 | california integrated diagnostics | MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT | April 8, 1987 |
| K864662 | american micro scan | CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS | March 25, 1987 |
| K864539 | boots-celltech diagnostics | MODIFIED IMAGEN(TM) CHLAMYDIA TEST | March 12, 1987 |
| K864888 | syva | MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST | February 25, 1987 |
| K864663 | kallestad diag, a div. of erbamont | PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM | February 2, 1987 |
| K864389 | american micro scan | CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST | December 4, 1986 |
| K863681 | kallestad laboratories | PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM | December 3, 1986 |
| K862354 | synbiotics | MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT | September 29, 1986 |