IMAGEN CHLAMYDIA TEST
FDA 510(k) clearance K844683 · decided 1985-02-06
Clearance details
- K-number
- K844683
- Device name
- IMAGEN CHLAMYDIA TEST
- Applicant
- Boots-Celltech Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-30
- Decision date
- 1985-02-06
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- IWP
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Berkshire, England, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boots-Celltech Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROTECTIVE RADIOGRAFIC GLOVE (K920538) | Burkhart Roentgen Intl., Inc. | 1992-05-29 |
| SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. (K904878) | Hpi, Inc. | 1991-03-07 |
| HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES (K905086) | Hpi, Inc. | 1990-12-03 |
| RADIATION PROTECTION GLOVES (K900972) | Infab Corp. | 1990-05-01 |
Recalls involving this device
No recalls on record reference this clearance.