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