510(k) K844683
K844683 is an FDA 510(k) premarket notification submitted by Boots-Celltech Diagnostics, Inc. for the device "IMAGEN CHLAMYDIA TEST". The FDA issued a decision of Substantially Equivalent on February 6, 1985. The device falls under product code IWP (Radiographic Protective Glove), a Class I device regulated under 21 CFR 892.6500. Boots-Celltech Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 1985
- Date Received
- November 30, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiographic Protective Glove
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type
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. -