FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
K Number: K885198
·
Decision Feb 23, 1989
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
18
Applicant Total
11
Review Days
69
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Basic Information
- Device Name
- 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
- K Number
- K885198
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1395
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Icn Biomedicals, Inc.
- Date Received
- December 16, 1988
- Decision Date
- February 23, 1989
- 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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ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
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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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|---|---|---|---|
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| K926106 | IMMUCHEM PHE-MW EA | Feb 8, 1995 | Substantially Equivalent |
| K922944 | IMMUCHEM LH-MW ELISA | Feb 2, 1993 | Substantially Equivalent |
| K922715 | IMMUCHEM PRL-MW ELISA | Oct 5, 1992 | Substantially Equivalent |
| K922376 | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT | Oct 5, 1992 | Substantially Equivalent |
| K920442 | IMMUCHEM TSH-MW ELISA | Mar 18, 1992 | Substantially Equivalent |
| K913963 | IMMUCHEM NEONATAL TSH-MP ELISA | Dec 13, 1991 | Substantially Equivalent |
| K902445 | LYMPHO SEP(TM) | Aug 22, 1990 | Substantially Equivalent |
| K881005 | IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG | May 27, 1988 | Substantially Equivalent |