KINETIC 610 ETHANOL
FDA 510(k) clearance K872180 · decided 1987-07-07
Clearance details
- K-number
- K872180
- Device name
- KINETIC 610 ETHANOL
- Applicant
- American Monitor Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-08
- Decision date
- 1987-07-07
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- DML
- Device class
- 2
- Regulation number
- 862.3040
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ETHANOL (K013538) | Abbott Laboratories | 2001-12-14 |
| SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (K993980) | Syva Co. | 2000-02-01 |
| ON.SITE ALCOHOL (K963197) | Ansys, Inc. | 1996-09-19 |
| AXSYM REA ETHANOL (K953765) | Abbott Laboratories | 1995-09-27 |
| BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY (K952839) | Boehringer Mannheim Corp. | 1995-08-24 |
| ON*SITE ALCOHOL (K923337) | Toxi-Lab, Inc. | 1993-01-12 |
| SIGMA PROCEDURE NO. 333-UV (K914777) | Sigma Diagnostics, Inc. | 1991-12-27 |
| RAICHEM(TM) ALCOHOL REAGENT (K874382) | Reagents Applications, Inc. | 1988-01-11 |
| EMDS(TM) ALCOHOL TESTPACKS, #67691/95 (K863419) | Em Diagnostic Systems, Inc. | 1986-09-29 |
| PARAMAX ALCOHOL REAGENT (K840769) | American Dade | 1984-04-13 |
| EMIT ST SERUM ETHYL ALCOHOL ASSAY (K840400) | Syva Co. | 1984-03-23 |
| EMIT ST URINE ETHYL ALCOHOL ASSAY (K840171) | Syva Co. | 1984-03-19 |
Recalls involving this device
No recalls on record reference this clearance.