FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMIT-TFG PRISMA THYROXINE ASSAY
K Number: K810586
·
Decision Mar 17, 1981
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
85
Applicant Total
448
Review Days
13
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
- EMIT-TFG PRISMA THYROXINE ASSAY
- K Number
- K810586
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Syva Co.
- Date Received
- March 4, 1981
- Decision Date
- March 17, 1981
- Product Code
- KLI
- 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 |
|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLI), ordered by most recent decision date.
VITROS® Automation Solutions
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GSP NEONATAL THYROXINE (T4)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS TOTAL T4 ASSAY
FDA 510(k)
FDA Class 2
·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 |