QuickScan 2000, (Windows 2000)
Catalogue number 1660002, listed by Helena Laboratories, Corp., United States, under Densitometeric, Protein Fractionation. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
Record
| Listed by | Helena Laboratories, Corp., United States |
|---|---|
| FDA product code | JQJ |
| Device type | Densitometeric, Protein Fractionation |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1630 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-03-17 |
| Record revised | 2022-09-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1660002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QuickScan Touch, Export Version 2, V800 | Helena Laboratories, Corp. | 1 |
| QuickScan 2000 (Windows 2000) Version 2.02 and V700 Scanner | Helena Laboratories, Corp. | 1 |
| QuickScan Touch, Export Version 2 | Helena Laboratories, Corp. | 1 |
| QuickScan Touch | Helena Laboratories, Corp. | 1 |
| QuickScan Touch Software & Key | Helena Laboratories, Corp. | 1 |
| Neutral Density Densitometer Control for QuickScan | Helena Laboratories, Corp. | 1 |
| QuickScan 2000 (Windows 2000) Version 2.02 and small Scanner | Helena Laboratories, Corp. | 1 |
| QuickScan 2000 Windows Software & Key | Helena Laboratories, Corp. | 1 |
| QuickScan (Windows 2000) Software, Version 2.02, and Key | Helena Laboratories, Corp. | 1 |
| QuickScan 2000 Software, Version 2.02 | Helena Laboratories, Corp. | 1 |
| QuickScan Touch, V800 | Helena Laboratories, Corp. | 1 |
| QuickScan 2000 (Windows 2000) Software and Computer, Version 2.01 | Helena Laboratories, Corp. | 1 |
Showing 12 of 13. All products under Densitometeric, Protein Fractionation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K901463 | 1990-06-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.