BACTIDROP ACRIDINE ORANGE
FDA 510(k) clearance K920974 · decided 1992-06-19
Clearance details
- K-number
- K920974
- Device name
- BACTIDROP ACRIDINE ORANGE
- Applicant
- Remel Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-02
- Decision date
- 1992-06-19
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- JFO
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lenexa, KS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| remel BactiDrop Acridine Orange, REF 21502, 50 per package. recall (Z-0266-2025) | Remel, Inc | 2024-10-30 |