FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ETHYL ALCOHOL SERUM CALIBRATOR
K Number: K810466
·
Decision Mar 6, 1981
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
6
Applicant Total
448
Review Days
11
Basic Information
- Device Name
- ETHYL ALCOHOL SERUM CALIBRATOR
- K Number
- K810466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3200
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- SYVA CO.
- Date Received
- February 23, 1981
- Decision Date
- March 6, 1981
- Product Code
- DNN
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DNN | Calibrators, Ethyl Alcohol | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DNN), ordered by most recent decision date.
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EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR
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Other Clearances by SYVA CO.
| K Number | Device Name | ||
|---|---|---|---|
| K011878 | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL | Aug 13, 2001 | Substantially Equivalent |
| K012257 | EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 | Aug 3, 2001 | Substantially Equivalent |
| K011947 | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL | Jul 2, 2001 | Substantially Equivalent |
| K011528 | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 | Jun 6, 2001 | Substantially Equivalent |
| K011347 | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 | May 17, 2001 | Substantially Equivalent |
| K993980 | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL | Feb 1, 2000 | Substantially Equivalent |
| K993981 | SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL | Feb 1, 2000 | Substantially Equivalent |
| K993029 | ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 | Jan 27, 2000 | Substantially Equivalent |
| K993031 | ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 | Jan 27, 2000 | Substantially Equivalent |
| K993988 | SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL | Jan 27, 2000 | Substantially Equivalent |