510(k) K803304
- Device
- ACRIDINE ORANGE STAIN
- Applicant
- REMEL CO.
- 510(k) number
- K803304
- Product code
- IDC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-02-12
- Date received
- 1980-12-30
- Regulation
- 864.1850
- Classification name
- Acridine Orange
- Medical specialty
- Hematology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3013160357
- 2013736
- 2242239
- 1119779
- 2247035
- 2025606
- 9610140
- 1924669
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IDC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K853187 | ACRIDINE ORANGE FLUORESCENT STAIN | Advanced Medical Technology, Inc. | 1985-08-13 |
| K812212 | ACRIDINE ORANGE STAIN | Carr-Scarborough Microbiologicals, Inc. | 1981-09-01 |
| K810040 | ACRIDINE ORANGE STAIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-02-12 |
Legacy Summary#
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FDA Review#
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