FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUMETER THEOPHYLLINE TEST
K Number: K972495
·
Decision Oct 10, 1997
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
70
Applicant Total
7
Review Days
99
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
- ACCUMETER THEOPHYLLINE TEST
- K Number
- K972495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chemtrak, Inc.
- Date Received
- July 3, 1997
- Decision Date
- October 10, 1997
- Product Code
- KLS
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| KLS | Enzyme Immunoassay, Theophylline | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLS), ordered by most recent decision date.
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EMIT CAFFEINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ROCHE ONLINE THEOPHYLLINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RANDOX THEOPHYLLINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Chemtrak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K965099 | ACCUMETER H. PYLORI TEST | Feb 20, 1997 | Substantially Equivalent |
| K960478 | ACCUMETER H. PYLORI TEST | Jun 27, 1996 | Substantially Equivalent |
| K943279 | ACCUMETER HDL CHOLESTEROL TEST | May 1, 1995 | Substantially Equivalent |
| K943599 | CHEM TRAK ACCUMETER | Mar 21, 1995 | Substantially Equivalent |
| K914432 | ACCUMETER(R) CHOLESTEROL SELF-TEST | Mar 2, 1993 | Substantially Equivalent |
| K905405 | CHEMTRAK ACCUMETER CHOLESTEROL TEST | Mar 19, 1991 | Substantially Equivalent |