Boehringer Mannheim Ethyl Alcohol Assay
FDA 510(k) K952839 · Boehringer Mannheim Corp.
510(k) numberK952839
Submission
- Device name
- Boehringer Mannheim Ethyl Alcohol Assay
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- June 21, 1995
- Decision date
- August 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DML – Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3040
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K013538 | EthanolDML · Traditional | Abbott Laboratories | 12/14/2001SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | Syva Co. | 02/01/2000SE |
| K963197 | On.Site AlcoholDML · Traditional | Ansys, Inc. | 09/19/1996SE |
| K953765 | Axsym Rea EthanolDML · Traditional | Abbott Laboratories | 09/27/1995SE |
| K923337 | On*Site AlcoholDML · Traditional | Toxi-Lab, Inc. | 01/12/1993SE |
| K914777 | Sigma Procedure No. 333-UVDML · Traditional | Sigma Diagnostics, Inc. | 12/27/1991SE |
| K874382 | Raichem(Tm) Alcohol ReagentDML · Traditional | Reagents Applications, Inc. | 01/11/1988SE |
| K872180 | Kinetic 610 EthanolDML · Traditional | American Monitor Corp. | 07/07/1987SE |
| K863419 | Emds(Tm) Alcohol Testpacks, #67691/95DML · Traditional | Em Diagnostic Systems, Inc. | 09/29/1986SE |
| K840769 | Paramax Alcohol ReagentDML · Traditional | American Dade | 04/13/1984SE |
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| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
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Questions and answers
When was Boehringer Mannheim Ethyl Alcohol Assay cleared by the FDA?
Boehringer Mannheim Ethyl Alcohol Assay (K952839) received a 510(k) decision of Substantially Equivalent on August 24, 1995, 64 days after the submission was received.
What is the product code of K952839?
The FDA product code is DML – Nad-Nadh, Specific Reagent For Alcohol Enzyme Method, a Class II (moderate risk) device regulated under 21 CFR 862.3040.