FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
K Number: K100682
·
Decision Jul 23, 2010
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
18
Applicant Total
22
Review Days
135
Basic Information
- Device Name
- GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
- K Number
- K100682
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1395
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- WALLAC OY
- Date Received
- March 10, 2010
- Decision Date
- July 23, 2010
- Product Code
- JLX
- 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 |
|---|---|---|---|
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JLX), ordered by most recent decision date.
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ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
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MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
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DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
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Other Clearances by WALLAC OY
| K Number | Device Name | ||
|---|---|---|---|
| DEN140010 | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM | Dec 15, 2014 | Unknown |
| K131284 | GSP NEONATAL BIOTINIDASE KIT | Nov 14, 2013 | 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 |
| K003664 | DELFIA NEONATAL IRT KIT, MODEL A005-110 | Feb 14, 2001 | Substantially Equivalent |