Pathfinder(Tm) Direct Detection Sys C. Trachomatis
FDA 510(k) K880031 · Kallestad Diag, A Div. of Erbamont, Inc.
510(k) numberK880031
Submission
- Device name
- Pathfinder(Tm) Direct Detection Sys C. Trachomatis
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
Chaska, MN, US - Received
- January 5, 1988
- Decision date
- March 17, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K941714 | Chlamydia Trachomatis Antigen TestLJP · Traditional | Neogenex | 07/18/1994SE |
| 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 |
| 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 |
|---|---|---|
| K910887 | QM300 Control G PackGTQ · Traditional | 06/17/1991SE |
| K910886 | QM300 Antistreptolysin O (Aso) Antigen PackGTQ · Traditional | 06/17/1991SE |
| K910885 | QM300 Calibrator G PackGTQ · Traditional | 06/17/1991SE |
| K904725 | Chlamydia System Software (CSS)LJC · Traditional | 01/14/1991SE |
| K902253 | Pathfinder(Tm) Chlamydia Microplate KitLJC · Traditional | 07/26/1990SE |
| K902462 | Modified QM300 Rheumatoid Factor TestDHR · Traditional | 06/21/1990SE |
| K900010 | NDS Cortisol Test Kit and NDS Cortisol CalibratorJFT · Traditional | 04/03/1990SE |
| K900009 | NDS Theophylline Test Kit & NDS TDM Calibrator SetKLS · Traditional | 03/29/1990SE |
| K897072 | NDS Thyroxine Test Kit & NDS Thyroxine CalibratorKLI · Traditional | 03/29/1990SE |
| K894947 | Platelia Toxo Igg KitLGO · Traditional | 03/23/1990SE |
Questions and answers
When was Pathfinder(Tm) Direct Detection Sys C. Trachomatis cleared by the FDA?
Pathfinder(Tm) Direct Detection Sys C. Trachomatis (K880031) received a 510(k) decision of Substantially Equivalent on March 17, 1988, 72 days after the submission was received.
What is the product code of K880031?
The FDA product code is LJP – Antiserum, Fluorescent, Chlamydia Trachomatis, a Class I (low risk) device regulated under 21 CFR 866.3120.