MANAN UBK ULTRASONIC GUIDED BIOPSY KIT
FDA 510(k) clearance K852105 · decided 1985-06-18
Clearance details
- K-number
- K852105
- Device name
- MANAN UBK ULTRASONIC GUIDED BIOPSY KIT
- Applicant
- Manan Manufacturing Co., Inc.
- Decision
- Unknown
- Date received
- 1985-05-15
- Decision date
- 1985-06-18
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- FCH
- Device class
- 1
- Regulation number
- 876.4730
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Skokie, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SIGMA 1 WOBBLER BIOPSY KIT (K882673) | Kontron Instruments, Inc. | 1988-07-28 |
Recalls involving this device
No recalls on record reference this clearance.