FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
17-HYDROXYPROGESTERONE TEST SET
K Number: K771729
·
Decision Oct 21, 1977
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
18
Applicant Total
13
Review Days
37
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
- 17-HYDROXYPROGESTERONE TEST SET
- K Number
- K771729
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1395
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Wien Laboratories, Inc.
- Date Received
- September 14, 1977
- Decision Date
- October 21, 1977
- 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
Other Clearances by Wien Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912850 | SHBG | Aug 12, 1991 | Substantially Equivalent |
| K834246 | PROGESTERONE TEST SET 125I 17-OH | Feb 4, 1984 | Substantially Equivalent |
| K832452 | ANDROSTENEDIONE TEST SET 125I | Sep 12, 1983 | Substantially Equivalent |
| K823200 | 125 I-DEHYDROEPIANDROSTERONE SULFATE | Nov 29, 1982 | Substantially Equivalent |
| K821653 | PROTRIPTYLINE TRI-CY TEST SET | Jun 14, 1982 | Substantially Equivalent |
| K821652 | DOXEPIN TRI-CY TEST SET | Jun 14, 1982 | Substantially Equivalent |
| K802728 | 125I-TESTOSTERONE TEST SET | Dec 11, 1980 | Substantially Equivalent |
| K792041 | DHEA-SULFATE TEST SET | Oct 30, 1979 | Substantially Equivalent |
| K781834 | TEST SET, 125 I-DIGOXIN | Jan 3, 1979 | Substantially Equivalent |
| K781599 | I-ESTRIOL TEST SET | Oct 17, 1978 | Substantially Equivalent |