FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCUSCREEN 17-HYDROXYPROGESTERONE
K Number: K934178
·
Decision Mar 30, 1995
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
18
Applicant Total
21
Review Days
580
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Basic Information
- Device Name
- ACCUSCREEN 17-HYDROXYPROGESTERONE
- K Number
- K934178
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1395
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Neometrics, Inc.
- Date Received
- August 27, 1993
- Decision Date
- March 30, 1995
- 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.
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
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FDA Class 1
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AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
FDA 510(k)
FDA Class 1
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ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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| K070150 | VASCUPUNCTURE PICC GUIDEWIRE | Feb 15, 2007 | Substantially Equivalent |
| K043398 | MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE | Mar 1, 2005 | Substantially Equivalent |
| K040786 | VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING | Apr 19, 2004 | Substantially Equivalent |
| K033321 | SELECTIVA SB GUIDEWIRE | Nov 5, 2003 | Substantially Equivalent |