FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GDS ENZYMATIC THEOPHYLLINE REAGENT
K Number: K891761
·
Decision May 16, 1989
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
4
Review Days
53
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GDS ENZYMATIC THEOPHYLLINE REAGENT
- K Number
- K891761
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Gds Diagnostics
- Date Received
- March 24, 1989
- Decision Date
- May 16, 1989
- Product Code
- LCY
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LCY | U.V. Spectrometry, Theophylline | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCY), ordered by most recent decision date.
THEOPHYLLINE ASSAY TO THE GEMSAEC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
THEOPHYLLINE ASSAY TO THE CENTRIFICHEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology