Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation Kit
FDA 510(k) K063675 · Diagnostic Hybrids, Inc.
510(k) numberK063675
Submission
- Device name
- Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation Kit
- Applicant
- Diagnostic Hybrids, Inc.
Athens, OH, US - Received
- December 11, 2006
- Decision date
- September 24, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K870946 | Monabrite Chlamydia Trachomatis Dir. Specimen TestLJP · Traditional | Serono Diagnostics, Inc. | 04/29/1987SE |
More from Serono Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K092882 | D3 Fastpoint L-Dfa Influenza A/Influenza B Virus Identification KitGNW · Traditional | 10/21/2009SE |
| K091171 | D3 Ultra Duet Dfa Respiratory Virus Identification KitOMG · Traditional | 09/11/2009SE |
| K092300 | Modification to D3 Ultra Dfa Respiratory Virus Screening & Id KitGNW · Special | 08/28/2009SE |
| K091753 | Elvis HSV Id and D3 Typing Test SystemGQL · Traditional | 08/28/2009SE |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional | 05/21/2009SE |
| K090073 | D3 Dfa Metapneumovirus Identification KitOMG · Traditional | 03/06/2009SE |
| K081928 | D3 Duet Dfa Rsv/Respiratory Virus Screening KitLKT · Traditional | 12/23/2008SE |
Questions and answers
When was Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation Kit cleared by the FDA?
Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation Kit (K063675) received a 510(k) decision of Substantially Equivalent on September 24, 2007, 287 days after the submission was received.
What is the product code of K063675?
The FDA product code is LJP – Antiserum, Fluorescent, Chlamydia Trachomatis, a Class I (low risk) device regulated under 21 CFR 866.3120.