Spectrum, Inc. 987-03897-000
by Spectrum Co.
Spectrum, Inc. 987-03897-000 (725600) is a device classified as Unclassified made by Spectrum Co., cleared under FDA 510(k) K863872 on 10 Feb 1987 and listed in FDA GUDID since 21 Jul 2017 (UDI-DI 00850301007846), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850301007846 | Date21 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK863872 | Date10 Feb 1987 | StatusActive |
Official records
- AccessGUDID record 00850301007846
- FDA 510(k) database K863872
Across registries
- FDA 510(k) K863872 decided 10 Feb 1987 Active
- FDA GUDID UDI-DI 00850301007846 listed 21 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K863872
- Listed FDA GUDID 00850301007846
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Spectrum, Inc.
- Generic name
- General specimen container IVD, no additive, sterile
- Model / Ref / Catalog
- 987-03897-000, 725600
- Description
- Specimine Container, 8 Oz, Non-Sterile
- Primary DI / UDI-DI
- 00850301007846
- 510(k) Number
- FDA product code
- LPZ
- GMDN term
- General specimen container IVD, no additive, sterile
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe