Ideia(Tm) Chlamydia Specimen Collection Kit
FDA 510(k) K864998 · Boots-Celltech Diagnostics, Inc.
510(k) numberK864998
Submission
- Device name
- Ideia(Tm) Chlamydia Specimen Collection Kit
- Applicant
- Boots-Celltech Diagnostics, Inc.
Berkshire, England, GB - Received
- December 22, 1986
- Decision date
- April 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSM – Culture Media, Non-Propagating Transport
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2390
- Specialty
- Microbiology
Other 510(k)s with product code JSM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport DeviceJSM · Traditional | Medical Wire & Equipment Company (Bath), Ltd. | 11/26/2025SE |
| K250205 | Babio® Virus Transport Kit (Non-inactivating)JSM · Traditional | Jinan Babio Biotechnology Co., Ltd. | 09/22/2025SE |
| K242576 | AllTest Viral Transport MediumJSM · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 04/04/2025SE |
| K232565 | UriSpongeJSM · Traditional | Copan Italia Spa | 10/11/2024SE |
| K220908 | Ensol EnTM Specimen Collection and Transport SystemJSM · Traditional | Ensol Biosciences, Inc. | 08/29/2024SE |
| K240235 | OmniTrans Transport SystemJSM · Traditional | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 08/19/2024SE |
| K233534 | Viral Transport MediumJSM · Traditional | Hardy Diagnostics | 08/02/2024SE |
| K233449 | Avantik VTMJSM · Traditional | Hanchang Medic Co., Ltd. (Han Chang Medic) | 07/15/2024SE |
| K232454 | Viral Transport Media (VTM)JSM · Traditional | Alb Luz | 05/03/2024SE |
| K232357 | Copan Universal Transport Medium (UTM-RT) SystemJSM · Traditional | Copan Italia Spa | 04/25/2024SE |
More from Copan Italia Spa
| 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 |
| K864539 | Modified Imagen(Tm) Chlamydia TestLJP · Traditional | 03/12/1987SE |
Questions and answers
When was Ideia(Tm) Chlamydia Specimen Collection Kit cleared by the FDA?
Ideia(Tm) Chlamydia Specimen Collection Kit (K864998) received a 510(k) decision of Substantially Equivalent on April 20, 1987, 119 days after the submission was received.
What is the product code of K864998?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.