FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇮 Finland
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
K Number: K944490
·
Decision Dec 9, 1994
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
22
Review Days
87
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Basic Information
- Device Name
- AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
- K Number
- K944490
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wallac OY
- Date Received
- September 13, 1994
- Decision Date
- December 9, 1994
- Product Code
- CGI
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CGI | Radioimmunoassay, Estriol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
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Other Clearances by Wallac OY
| K Number | Device Name | ||
|---|---|---|---|
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| K131284 | GSP NEONATAL BIOTINIDASE KIT | Nov 14, 2013 | Substantially Equivalent |
| K100682 | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | Jul 23, 2010 | Substantially Equivalent |
| K081922 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Apr 16, 2009 | Substantially Equivalent |
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | Aug 7, 2008 | Substantially Equivalent |
| K070889 | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 | Apr 14, 2008 | Substantially Equivalent |
| K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 | Mar 8, 2006 | Substantially Equivalent |
| K050960 | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | Jul 11, 2005 | Substantially Equivalent |
| K042424 | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Sep 30, 2004 | Substantially Equivalent |
| K042425 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Sep 30, 2004 | Substantially Equivalent |