510(k) K953765
- Device
- AXSYM REA ETHANOL
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K953765
- Product code
- DML
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-09-27
- Date received
- 1995-08-11
- Regulation
- 862.3040
- Classification name
- Nad-nadh, Specific Reagent For Alcohol Enzyme Method
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DOUG KENTZ
- Address
- Dept: 09v8 Bldg: Ap5-2 100 Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 9610529
- 2517506
- 9610126
- 3006198300
- 3003795116
- 2432235
Source Documents#
Other 510(k) Records For Product Code DML #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013538 | ETHANOL | Abbott Laboratories | 2001-12-14 |
| K993980 | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL | Syva Co. | 2000-02-01 |
| K963197 | ON.SITE ALCOHOL | Ansys, Inc. | 1996-09-19 |
| K952839 | BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY | Boehringer Mannheim Corp. | 1995-08-24 |
| K923337 | ON*SITE ALCOHOL | Toxi-Lab, Inc. | 1993-01-12 |
| K914777 | SIGMA PROCEDURE NO. 333-UV | Sigma Diagnostics, Inc. | 1991-12-27 |
| K874382 | RAICHEM(TM) ALCOHOL REAGENT | Reagents Applications, Inc. | 1988-01-11 |
| K872180 | KINETIC 610 ETHANOL | American Monitor Corp. | 1987-07-07 |
| K863419 | EMDS(TM) ALCOHOL TESTPACKS, #67691/95 | Em Diagnostic Systems, Inc. | 1986-09-29 |
| K840769 | PARAMAX ALCOHOL REAGENT | American Dade | 1984-04-13 |
| K840400 | EMIT ST SERUM ETHYL ALCOHOL ASSAY | Syva Co. | 1984-03-23 |
| K840171 | EMIT ST URINE ETHYL ALCOHOL ASSAY | Syva Co. | 1984-03-19 |
Legacy Summary#
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FDA Review#
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