FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
K Number: K973350
·
Decision Feb 9, 1998
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
18
Applicant Total
319
Review Days
157
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Basic Information
- Device Name
- BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
- K Number
- K973350
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1395
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Rad
- Date Received
- September 5, 1997
- Decision Date
- February 9, 1998
- 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
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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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