Imagen Chlamydia Test
FDA 510(k) K844683 · Boots-Celltech Diagnostics, Inc.
510(k) numberK844683
Submission
- Device name
- Imagen Chlamydia Test
- Applicant
- Boots-Celltech Diagnostics, Inc.
Berkshire, England, GB - Received
- November 30, 1984
- Decision date
- February 6, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IWP – Radiographic Protective Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.6500
- Specialty
- Radiology
A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. -
Other 510(k)s with product code IWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K920538 | Protective Radiografic GloveIWP · Traditional | Burkhart Roentgen Intl., Inc. | 05/29/1992SE |
| K904878 | Sensi Rads Lead Latex Radiation Prot. Glove, Ster.IWP · Traditional | Hpi, Inc. | 03/07/1991SE |
| K905086 | Hpi Tri-Rads Vinyl Radiation Protection GlovesIWP · Traditional | Hpi, Inc. | 12/03/1990SE |
| K900972 | Radiation Protection GlovesIWP · Traditional | Infab Corp. | 05/01/1990SE |
More from Infab Corp.
| 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 Imagen Chlamydia Test cleared by the FDA?
Imagen Chlamydia Test (K844683) received a 510(k) decision of Substantially Equivalent on February 6, 1985, 68 days after the submission was received.
What is the product code of K844683?
The FDA product code is IWP – Radiographic Protective Glove, a Class I (low risk) device regulated under 21 CFR 892.6500.