HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL
FDA 510(k) clearance K901276 · decided 1990-04-26
Clearance details
- K-number
- K901276
- Device name
- HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-03-19
- Decision date
- 1990-04-26
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- DIT
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Los Angeles, CA, 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 |
|---|---|---|
| QUICK SCREEN ONE STEP AMPHETAMINE TEST (K972577) | Phamatech | 1997-08-20 |
| MICROLINE SCREEN FOR METHAMPHETAMINE (K910525) | Drug Screening Systems, Inc. | 1991-04-05 |
| DRUG ABUSE DIPSTICKS (K790805) | Technical Resources, Inc. | 1979-06-06 |
Recalls involving this device
No recalls on record reference this clearance.