Ultra Chem Ban-Uv #65080 & 65081
FDA 510(k) K823472 · Emd Chemicals, Inc.
510(k) numberK823472
Submission
- Device name
- Ultra Chem Ban-Uv #65080 & 65081
- Applicant
- Emd Chemicals, Inc.
Mchenry, IL, US - Received
- November 22, 1982
- Decision date
- December 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K203771 | Urea Nitrogen2CDQ · Traditional | Abbott Ireland Diagnostics Division | 05/31/2022SE |
| K140690 | BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerCDQ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 09/02/2014SE |
| K110675 | Easyra Urea Nitrogen and Creatinine ReagentsCDQ · Traditional | Medica Corp. | 04/21/2011SE |
| K073295 | Urea/Bun, Scal, Nortrol, AbtrolCDQ · Traditional | Thermofisher Scientific OY | 05/29/2008SE |
| K070146 | Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPCDQ · Traditional | Horiba Abx | 10/12/2007SE |
| K060120 | Teco CX3 Reagent Set for Synchron CX SystemCDQ · Traditional | Teco Diagnostics | 03/27/2006SE |
| K041051 | Raichem Bun Rate Reagent (Liquid)CDQ · Traditional | Hemagen Diagnostics, Inc. | 06/30/2004SE |
| K024182 | Precision Systems Analette Chemistry Analyzer Stanbio Laboratory ReagentsCDQ · Traditional | Precision Systems, Inc. | 03/03/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | Elan Diagnostics | 07/12/2002SE |
| K012649 | Raichem Bun Rate ReagentCDQ · Traditional | Hemagen Diagnostics, Inc. | 10/15/2001SE |
More from Hemagen Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K031367 | Duopath Verotoxins Glisa TestGNA · Traditional | 01/23/2004SE |
| K990516 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | 03/31/1999SE |
| K981926 | Ethyl Alcohol Clinical Standard SolutionsDLJ · Traditional | 07/22/1998SE |
| K973054 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | 10/01/1997SE |
| K951494 | Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)CIJ · Traditional | 12/11/1995SE |
| K951750 | Glucose Test Item Number 97375/94LFR · Traditional | 09/06/1995SE |
| K950234 | Total Protein Test (Tpro) Item Number: XXXXX/R1. R2CEK · Traditional | 06/14/1995SE |
| K950128 | Total Protein Test (Tpro) Item XXXXX/R1. R2CEK · Traditional | 05/15/1995SE |
| K945322 | Phosphorus Test (Phos) Item Number 65416CEO · Traditional | 12/07/1994SE |
| K945368 | Phosphorus Test (Phos)CEO · Traditional | 12/02/1994SE |
Questions and answers
When was Ultra Chem Ban-Uv #65080 & 65081 cleared by the FDA?
Ultra Chem Ban-Uv #65080 & 65081 (K823472) received a 510(k) decision of Substantially Equivalent on December 28, 1982, 36 days after the submission was received.
What is the product code of K823472?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.