FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COAT-A-COUNT ANDROSTENEDIONE RIA KIT
K Number: K844398
·
Decision Dec 10, 1984
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
9
Applicant Total
321
Review Days
27
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Basic Information
- Device Name
- COAT-A-COUNT ANDROSTENEDIONE RIA KIT
- K Number
- K844398
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1075
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Products Corp.
- Date Received
- November 13, 1984
- Decision Date
- December 10, 1984
- Product Code
- CIZ
- 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 |
|---|---|---|---|
| CIZ | Radioimmunoassay, Androstenedione | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CIZ), ordered by most recent decision date.
ACTIVE ANDROSTENEDIONE EIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COAT-A-COUNT DIRECT ANDROSTENEDIONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACTIVE ANDROSTANEDIOL GLUCURONIDE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANDROSTENEDIONE 125I KIT BY RIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL ANDROSTENEDIONE RIA (DSL # 4200)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Diagnostic Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | Dec 5, 2006 | Substantially Equivalent |
| K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | Jan 21, 2004 | Substantially Equivalent |
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | Dec 12, 2003 | Substantially Equivalent |
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE | Oct 10, 2003 | Substantially Equivalent |
| K023152 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE | Dec 17, 2002 | Substantially Equivalent |
| K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL | Dec 9, 2002 | Substantially Equivalent |
| 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 |