510(k) K853081
- Device
- AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET
- Applicant
- ADVANCED MEDICAL TECHNOLOGY, INC.
- 510(k) number
- K853081
- Product code
- KJK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-08-13
- Date received
- 1985-07-23
- Regulation
- 864.1850
- Classification name
- Auramine O
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID A WALL
- Address
- Suite 502, Perimeter Park 3351 Wrightsboro, Rd. Augusta GA US 30909 30909
FDA Registration Numbers#
- 3008174888
- 9610140
- 2025606
- 2013736
- 1119779
- 2247035
- 1045125
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KJK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K812274 | AURAMINE O MYCROBACTERIAL STAIN SET | Carr-Scarborough Microbiologicals, Inc. | 1981-09-01 |
Legacy Summary#
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FDA Review#
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