FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY
K Number: K950524
·
Decision May 15, 1995
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
27
Applicant Total
15
Review Days
105
Basic Information
- Device Name
- NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY
- K Number
- K950524
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1245
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- NICHOLS INSTITUTE
- Date Received
- January 30, 1995
- Decision Date
- May 15, 1995
- Product Code
- JKC
- 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 |
|---|---|---|---|
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | FDA class 1 | Clinical Chemistry |
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Other Clearances by NICHOLS INSTITUTE
| K Number | Device Name | ||
|---|---|---|---|
| K952559 | ERYTHROPOIETIN IMMUNOASSAY KIT | May 29, 1996 | Substantially Equivalent |
| K952505 | INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) | Jul 3, 1995 | Substantially Equivalent |
| K946247 | IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 | Jun 23, 1995 | Substantially Equivalent |
| K932650 | ERYTHROPOIETIN IMMUNOASSAY KIT | Mar 11, 1994 | Substantially Equivalent |
| K931600 | CHEMILUMINESCENCE FREE T3 IMMUNOASSAY | Sep 8, 1993 | Substantially Equivalent |
| K931777 | APO A-1 CHEMILUMINESCENCE ASSAY | Aug 16, 1993 | Substantially Equivalent |
| K931601 | CHEMILUMINESCENCE DHEA-S IMMUNOASSAY | Jul 27, 1993 | Substantially Equivalent |
| K926396 | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT | Jul 27, 1993 | Substantially Equivalent |
| K931311 | THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT | May 14, 1993 | Substantially Equivalent |
| K930777 | THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT | Apr 8, 1993 | Substantially Equivalent |