510(k) K863915
- Device
- SHAPE-ACTIO METAL TOXICOLOGY CONTROL
- Applicant
- SHAPE PRODUCTS CO.
- 510(k) number
- K863915
- Product code
- DIE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-24
- Date received
- 1986-10-08
- Regulation
- 862.3280
- Classification name
- Heavy Metals Control Materials
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DWIGHT GUSTAFSON
- Address
- 1127 57th Ave. Oakland CA US 94621 94621
FDA Registration Numbers#
- 2016706
- 3010127294
- 3001431095
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DIE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020610 | LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 | Bio-Rad | 2002-04-22 |
| K990928 | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 | Bio-Rad | 1999-04-16 |
| K891691 | LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II | Bio-Rad | 1989-12-19 |
| K890721 | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | Actio, Inc. | 1989-04-10 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases