CR Perfect
FDA 510(k) K950142 · Chimera Research & Chemical, Inc.
510(k) numberK950142
Submission
- Device name
- CR Perfect
- Applicant
- Chimera Research & Chemical, Inc.
Largo, FL, US - Received
- January 13, 1995
- Decision date
- May 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGX – Alkaline Picrate, Colorimetry, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252206 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | Nova Biomedical Corporation | 01/09/2026SE |
| K251058 | Tru Kidney Health Test Panel; Tru AnalyzerCGX · Traditional | Truvian Health | 11/26/2025SE |
| K242685 | Atellica® CH Creatinine_3 (Crea3)CGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/04/2024SE |
| K221813 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | Nova Biomedical Corporation | 11/19/2024SE |
| K210452 | Creatinine2CGX · Traditional | Abbott Ireland Diagnostics Division | 03/22/2022SE |
| K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)CGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/15/2016SE |
| K132638 | Dimension Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/27/2014SE |
| K133728 | Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/24/2014SE |
| K123586 | Easyra Creatinine ReagentCGX · Special | Medica Corporation | 05/15/2013SE |
| K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…CGX · Abbreviated | Horiba Abx SAS | 04/30/2012SE |
More from Horiba Abx SAS
| 510(k) | Device | Decision |
|---|---|---|
| K970087 | CR PerfectCGX · Traditional | 03/06/1997SE |
| K951877 | Automated Analysis Assay for Bilirubin in UrineKQO · Traditional | 05/14/1996SE |
| K953393 | Tox Perfect a TubeDMP · Traditional | 10/06/1995SE |
| K952501 | Tox Perfect B Tubes and ReagentsDPM · Traditional | 08/24/1995SE |
| K940768 | Ad PerfectIFT · Traditional | 02/17/1995SE |
| K935408 | Ua PerfectKQO · Traditional | 06/13/1994SE |
Questions and answers
When was CR Perfect cleared by the FDA?
CR Perfect (K950142) received a 510(k) decision of Substantially Equivalent on May 25, 1995, 132 days after the submission was received.
What is the product code of K950142?
The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.