FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLINESTERASE
K Number: K863111
·
Decision Sep 11, 1986
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
25
Applicant Total
34
Review Days
29
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Basic Information
- Device Name
- CHOLINESTERASE
- K Number
- K863111
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3240
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- J. D. Assoc.
- Date Received
- August 13, 1986
- Decision Date
- September 11, 1986
- Product Code
- DIH
- 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 |
|---|---|---|---|
| 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.
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SENTINEL CHOLINESTERASE LIQUID
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OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
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WIENER LAB COLINESTERASA AA
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FDA Class 1
·Clinical Toxicology
ADVIA 1650 CHOLINESTERASE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Other Clearances by J. D. Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K863103 | PEG 6,000 | Jan 13, 1987 | Substantially Equivalent |
| K863054 | AST S.C.E. (GOT) | Jan 13, 1987 | Substantially Equivalent |
| K863069 | MAGNESIOMETER | Dec 31, 1986 | Substantially Equivalent |
| K863079 | CREATINKINETIC | Dec 12, 1986 | Substantially Equivalent |
| K863112 | PROTEINMETER | Dec 10, 1986 | Substantially Equivalent |
| K863068 | LDH S.C.E. | Dec 10, 1986 | Substantially Equivalent |
| K863053 | ALT S.C.E. (GPT) | Dec 10, 1986 | Substantially Equivalent |
| K863066 | TRANSFERMETER | Dec 4, 1986 | Substantially Equivalent |
| K863109 | FERROFAST | Nov 24, 1986 | Substantially Equivalent |
| K863102 | GLUCOMETER-E | Nov 24, 1986 | Substantially Equivalent |