FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE
K Number: K914171
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
25
Applicant Total
13
Review Days
92
Basic Information
- Device Name
- IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE
- K Number
- K914171
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3240
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- TECH INTL. CO.
- Date Received
- September 17, 1991
- Decision Date
- December 18, 1991
- Product Code
- DIH
- 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 |
|---|---|---|---|
| DIH | Colorimetry, Cholinesterase | FDA class 1 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIH), ordered by most recent decision date.
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
FDA 510(k)
FDA Class 1
·Clinical Toxicology
CHOLINESTERASE GEN.2 TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Toxicology
SENTINEL CHOLINESTERASE LIQUID
FDA 510(k)
FDA Class 1
·Clinical Toxicology
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
WIENER LAB COLINESTERASA AA
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ADVIA 1650 CHOLINESTERASE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Other Clearances by TECH INTL. CO.
| K Number | Device Name | ||
|---|---|---|---|
| K915704 | AMYLASE (KINETIC) REAGENT SET | Jun 28, 1996 | Substantially Equivalent |
| K915705 | ACID PHOSPHATASE REAGENT SET | Feb 27, 1992 | Substantially Equivalent |
| K915707 | AMMONIA REAGENT SET | Feb 26, 1992 | Substantially Equivalent |
| K914158 | URIC ACID REAGENT SET | Feb 21, 1992 | Substantially Equivalent |
| K915706 | LIPASE REAGENT SET | Feb 18, 1992 | Substantially Equivalent |
| K915710 | AMYLASE (COLORIMETRIC) REAGENT SET | Jan 30, 1992 | Substantially Equivalent |
| K914160 | CHOLESTEROL REGEANT SET | Jan 30, 1992 | Substantially Equivalent |
| K915709 | CREATINE KINASE-MB (CK-MB) REAGENT SET | Jan 27, 1992 | Substantially Equivalent |
| K914159 | GLUCOSE REAGENT SET | Jan 27, 1992 | Substantially Equivalent |
| K915708 | INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET | Jan 22, 1992 | Substantially Equivalent |