510(k) K913125
- Device
- Roche Reagent For Ethanol
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K913125
- Product code
- DIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-08-12
- Date received
- 1991-07-15
- Regulation
- 862.3040
- Classification name
- Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL L KRIEGER
- Address
- One Sunset Ave. Montclair NJ US 07042 07042
FDA Registration Numbers#
- 2020952
- 3013660430
- 8020316
- 3006198300
- 3005360469
- 3003795116
- 2030861
- 3007606081
- 2432235
- 9610529
- 2060833
- 1832216
- 3002807310
- 1649661
- 2517506
- 1827821
- 3008517993
- 3009238284
- 1825396
- 3004635103
- 9610126
- 2030633
- 1220972
- 3003610499
- 3023322455
Source Documents#
510(k) summary PDF not indicated by FDA
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| K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 | Lin-Zhi International, Inc. | 2003-10-03 |
| K023184 | ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Bayer Diagnostics Corp. | 2002-11-18 |
| K010960 | EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 | Syva Co., Dade Behring, Inc. | 2001-04-26 |
| K001286 | ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 | Diagnostic Chemicals , Ltd. | 2000-06-20 |