510(k) K972725
- Device
- ALCOHOL REAGENT SET
- Applicant
- POINTE SCIENTIFIC, INC.
- 510(k) number
- K972725
- Product code
- DIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-09-25
- Date received
- 1997-07-21
- Regulation
- 862.3040
- Classification name
- Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM F WALTERS
- Address
- 1025 John A. Papalas Dr. Lincoln Park MI US 48146 48146
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
Other 510(k) Records For Product Code DIC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250609 | Sober Self-Test | Sober Ip, LLC | 2025-09-15 |
| K181553 | Immunalysis Ethyl Alcohol Enzyme Assay | Immunalysis Corporation | 2018-10-31 |
| K121247 | ALCO-SCREEN | Chematics, Inc. | 2013-03-22 |
| K121256 | ALCO-SCREEN 02 | Chematics, Inc. | 2012-09-12 |
| K111005 | ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL | Medica Corp. | 2011-11-15 |
| K111206 | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | Teco Diagnostics | 2011-10-04 |
| K092273 | RANDOX ETHANOL ASSAY | Randox Laboratories, Ltd. | 2010-11-01 |
| K093879 | MISSION SALIVA ALCOHOL TEST STRIP | ACON Laboratories, Inc. | 2010-08-06 |
| K071811 | ETOH FLEX REAGENT CARTRIDGE (DF22) | Dade Behring, Inc. | 2007-08-24 |
| K070853 | DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 | Dade Behring, Inc. | 2007-06-13 |
| K061792 | DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI | Dade Behring, Inc. | 2006-07-18 |
| 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 |
Legacy Summary#
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FDA Review#
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