ACRIDINE ORANGE STAIN
FDA 510(k) clearance K803304 · decided 1981-02-12
Clearance details
- K-number
- K803304
- Device name
- ACRIDINE ORANGE STAIN
- Applicant
- Remel Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-30
- Decision date
- 1981-02-12
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- IDC
- 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 |
|---|---|---|
| ACRIDINE ORANGE FLUORESCENT STAIN (K853187) | Advanced Medical Technology, Inc. | 1985-08-13 |
| ACRIDINE ORANGE STAIN (K812212) | Carr-Scarborough Microbiologicals, Inc. | 1981-09-01 |
| ACRIDINE ORANGE STAIN (K810040) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-02-12 |
Recalls involving this device
No recalls on record reference this clearance.