FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
K Number: K860335
·
Decision Apr 24, 1986
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
18
Applicant Total
321
Review Days
85
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Basic Information
- Device Name
- COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
- K Number
- K860335
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1395
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Products Corp.
- Date Received
- January 29, 1986
- Decision Date
- April 24, 1986
- 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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AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
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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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FDA Class 1
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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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| K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | Aug 21, 2002 | Substantially Equivalent |
| K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Jul 22, 2002 | Substantially Equivalent |
| K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | Jun 3, 2002 | Substantially Equivalent |
| K021208 | IMMULITE 2000 MIXED ALLERGEN PANELS | May 30, 2002 | Substantially Equivalent |