FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYVA ETS SYSTEM
K Number: K863245
·
Decision Mar 13, 1987
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
448
Review Days
203
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SYVA ETS SYSTEM
- K Number
- K863245
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Syva Co.
- Date Received
- August 22, 1986
- Decision Date
- March 13, 1987
- Product Code
- JJF
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJF), ordered by most recent decision date.
ETI-MAX 3000
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIGHTCYCLER INSTRUMENT VERSION 1.2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ROCHE COBAS TAQMAN ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARESIDE ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |
| K993981 | SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL | Feb 1, 2000 | Substantially Equivalent |
| K993980 | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL | Feb 1, 2000 | Substantially Equivalent |
| K993987 | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL | Jan 27, 2000 | Substantially Equivalent |
| K993982 | SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL | Jan 27, 2000 | Substantially Equivalent |
| K993988 | SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL | Jan 27, 2000 | Substantially Equivalent |