Data / Medical devices / United States / SCITECK Diagnostics
SCITECK Diagnostics: FDA-registered device maker in Fletcher, NC, United States, 6 510(k) clearances
SCITECK Diagnostics is registered with the FDA (registration 3004875840) in Fletcher, NC, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 6, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004875840
- Address
- 317 Rutledge Road, Fletcher, NC, United States, 28732
- Owner or operator
- Sciteck (10050379)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 10, 2015
- Registered through
- 2026
- Brand names listed
- AutoUA, AutoUA Automated Urinalysis System - AUA-450, SVT Aldehydes Reagent, SVT Creatinine Reagent, UA PERFECT, aD PERFECT, cR PERFECT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alkaline Picrate, Colorimetry, Creatinine | CGX | 2 | Manufacturer | accessdata.fda.gov |
| Automated Urinalysis System | KQO | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Manufacturer | accessdata.fda.gov |
| Glutaraldehyde | IFT | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 6, 1997 | K970087 | CR PERFECT | CGX | Substantially Equivalent | Chimera Research & Chemical, Inc. | accessdata.fda.gov |
| June 21, 1996 | K954514 | UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE | KQO | Substantially Equivalent | Sciteck Diagnostics, Inc. | accessdata.fda.gov |
| May 14, 1996 | K951877 | AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE | KQO | Substantially Equivalent | Chimera Research & Chemical, Inc. | accessdata.fda.gov |
| May 25, 1995 | K950142 | CR PERFECT | CGX | Substantially Equivalent | Chimera Research & Chemical, Inc. | accessdata.fda.gov |
| February 17, 1995 | K940768 | AD PERFECT | IFT | Substantially Equivalent | Chimera Research & Chemical, Inc. | accessdata.fda.gov |
| June 13, 1994 | K935408 | UA PERFECT | KQO | Substantially Equivalent | Chimera Research & Chemical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Urinalysis System
- All makers of Glutaraldehyde
- All makers of Calibrator, Secondary
- All makers of Alkaline Picrate, Colorimetry, Creatinine
Updated March 6, 1997. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.