AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET
FDA 510(k) clearance K853081 · decided 1985-08-13
Clearance details
- K-number
- K853081
- Device name
- AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET
- Applicant
- Advanced Medical Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-23
- Decision date
- 1985-08-13
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- KJK
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Augusta, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Advanced Medical Technology
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 |
|---|---|---|
| AURAMINE O MYCROBACTERIAL STAIN SET (K812274) | Carr-Scarborough Microbiologicals, Inc. | 1981-09-01 |
Recalls involving this device
No recalls on record reference this clearance.