Modified Imagen(Tm) Chlamydia Test
FDA 510(k) K864539 · Boots-Celltech Diagnostics, Inc.
510(k) numberK864539
Submission
- Device name
- Modified Imagen(Tm) Chlamydia Test
- Applicant
- Boots-Celltech Diagnostics, Inc.
Berkshire, England, GB - Received
- November 19, 1986
- Decision date
- March 12, 1987
- 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 |
|---|---|---|
| K871877 | Ideia Herpes Simplex Virus TestLGC · Traditional | 11/17/1989SE |
| K880799 | Modified Ideia Chlamydia TestLJC · Traditional | 12/08/1988SE |
| K880758 | Sucrosep Specific Immunoradiometric AssayCEP · Traditional | 04/18/1988SE |
| K874875 | Chemelia Free THYROXINE(FT4)/ENZYME Immuno. (Eia)CEC · Traditional | 03/24/1988SE |
| K872958 | Imagen Influenza Virus a and B TestmiGNX · Traditional | 02/24/1988SE |
| K872843 | Oveia (TM) Dual AnalyteJLP · Traditional | 02/02/1988SE |
| K873625 | Chemelia Enzyme Immunoassay for (TSH)JLM · Traditional | 10/20/1987SE |
| K872056 | Modified (Directions for Use) for Ideia(Tm) TestLJC · Traditional | 06/15/1987SE |
| K870602 | Imagen Herpes Simplex Virus (HSV) Typing TestGQN · Traditional | 05/08/1987SE |
| K864998 | Ideia(Tm) Chlamydia Specimen Collection KitJSM · Traditional | 04/20/1987SE |
Questions and answers
When was Modified Imagen(Tm) Chlamydia Test cleared by the FDA?
Modified Imagen(Tm) Chlamydia Test (K864539) received a 510(k) decision of Substantially Equivalent on March 12, 1987, 113 days after the submission was received.
What is the product code of K864539?
The FDA product code is LJP – Antiserum, Fluorescent, Chlamydia Trachomatis, a Class I (low risk) device regulated under 21 CFR 866.3120.