FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BETA SCAN TRENDS METER
K Number: K851822
·
Decision Oct 3, 1985
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
12
Review Days
160
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Basic Information
- Device Name
- BETA SCAN TRENDS METER
- K Number
- K851822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Orange Medical Instruments, Inc.
- Date Received
- April 26, 1985
- Decision Date
- October 3, 1985
- Product Code
- CGA
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Orange Medical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K860808 | CONTINUCATH | Mar 13, 1986 | Substantially Equivalent |
| K844796 | MICRO-BETA U100 SYRINGE | Dec 18, 1984 | Substantially Equivalent |
| K843882 | TRENDS LANCET | Nov 5, 1984 | Substantially Equivalent |
| K841369 | BETA SCAN DRYSTIX | Aug 23, 1984 | Substantially Equivalent |
| K833705 | BETAJECT BD U100 | May 9, 1984 | Substantially Equivalent |
| K833706 | CLICK-COUNT U100 INSULIN SYRINGE | Apr 5, 1984 | Substantially Equivalent |
| K832691 | BETA SCAN REAGENT STRIP | Nov 14, 1983 | Substantially Equivalent |
| K832793 | NEOCATH 1000 W/HEPCOTE | Sep 26, 1983 | Substantially Equivalent |
| K831897 | BETA I PROGRAMMABLE INFUSION PUMP | Aug 12, 1983 | Substantially Equivalent |
| K831523 | BETA SCAN NORMAL CONTROL SOLUTION | Jul 19, 1983 | Substantially Equivalent |