510(k) K802620
- Device
- Emit-stm Ethyl Alcohol Urine Calibrator
- Applicant
- SYVA CO.
- 510(k) number
- K802620
- Product code
- DNN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-10-31
- Date received
- 1980-10-20
- Regulation
- 862.3200
- Classification name
- Calibrators, Ethyl Alcohol
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010939897
- 2030861
- 3003610499
- 3003951180
- 1221645
- 1827821
- 2250051
- 2050010
- 2020952
- 3005333358
- 2050012
- 3032147516
- 1319808
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DNN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990516 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | 1999-03-31 |
| K973054 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | 1997-10-01 |
| K924733 | ETHYL ALCOHOL CALIBRATORS & CONTROL | Diagnostic Reagents, Inc. | 1992-12-09 |
| K882117 | ETHYL ALCOHOL STANDARD | Verichem Laboratories, Inc. | 1988-08-04 |
| K853532 | ALCOHOL CALIBRATORS | Diagnostic Systems | 1985-09-16 |
| K810466 | ETHYL ALCOHOL SERUM CALIBRATOR | Syva Co. | 1981-03-06 |