Anti-Chlamydia Trachomatis Kit
FDA 510(k) K842658 · Amico Lab, Inc.
510(k) numberK842658
Submission
- Device name
- Anti-Chlamydia Trachomatis Kit
- Applicant
- Amico Lab, Inc.
Mchenry, IL, US - Received
- July 10, 1984
- Decision date
- October 1, 1984
- 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 |
| 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 |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K842662 | Anti-Epstein-Barr Virus KitGNP · Traditional | 12/12/1985SE |
| K842663 | Anti-Herpes Simplex Virus Type 1 or 2GQO · Traditional | 12/06/1985SE |
| K842661 | Anti-Cytomegalovirus KitGQI · Traditional | 12/06/1985SE |
| K842531 | Amizyme-Hsv Types 1 & 2 Test KitsGQO · Traditional | 12/06/1985SE |
| K842530 | Amizyme-Ebv Test KitGNP · Traditional | 12/06/1985SE |
| K842529 | Amizyme-Cmv KitGQI · Traditional | 12/06/1985SE |
| K842660 | Anti-Schistosoma Species KitGNH · Traditional | 10/30/1984SE |
| K842525 | Amizyme-C Trachomatis Test KitLJP · Traditional | 10/01/1984SE |
| K842533 | Amizyme-Andna Test KitLJM · Traditional | 09/20/1984SE |
| K842532 | Amizyme-Ana Test KitLJM · Traditional | 09/20/1984SE |
Questions and answers
When was Anti-Chlamydia Trachomatis Kit cleared by the FDA?
Anti-Chlamydia Trachomatis Kit (K842658) received a 510(k) decision of Substantially Equivalent on October 1, 1984, 83 days after the submission was received.
What is the product code of K842658?
The FDA product code is LJP – Antiserum, Fluorescent, Chlamydia Trachomatis, a Class I (low risk) device regulated under 21 CFR 866.3120.