SHAPE-ACTIO METAL TOXICOLOGY CONTROL
FDA 510(k) clearance K863915 · decided 1986-11-24
Clearance details
- K-number
- K863915
- Device name
- SHAPE-ACTIO METAL TOXICOLOGY CONTROL
- Applicant
- Shape Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-08
- Decision date
- 1986-11-24
- Days to decision
- 47 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
+ Add to Predicate Builder ◉ Watch Shape Products Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K890721) | Actio, Inc. | 1989-04-10 |
Recalls involving this device
No recalls on record reference this clearance.