SHAPE-ACTIO METAL TOXICOLOGY CONTROL
FDA 510(k) clearance K890721 · decided 1989-04-10
Clearance details
- K-number
- K890721
- Device name
- SHAPE-ACTIO METAL TOXICOLOGY CONTROL
- Applicant
- Actio, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-13
- Decision date
- 1989-04-10
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- DIE
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Oakland, 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 |
|---|---|---|
| LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 (K020610) | Bio-Rad | 2002-04-22 |
| LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 (K990928) | Bio-Rad | 1999-04-16 |
| LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II (K891691) | Bio-Rad | 1989-12-19 |
| SHAPE-ACTIO METAL TOXICOLOGY CONTROL (K863915) | Shape Products Co. | 1986-11-24 |
Recalls involving this device
No recalls on record reference this clearance.