FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APO A-1 CHEMILUMINESCENCE ASSAY
K Number: K931777
·
Decision Aug 16, 1993
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
15
Review Days
129
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Basic Information
- Device Name
- APO A-1 CHEMILUMINESCENCE ASSAY
- K Number
- K931777
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nichols Institute
- Date Received
- April 9, 1993
- Decision Date
- August 16, 1993
- Product Code
- MSJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| MSJ | Apolipoproteins | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSJ), ordered by most recent decision date.
DIAZYME APOLIPOPROTEIN A-1 ASSAY
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DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
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DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
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8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
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SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
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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 |
| K950524 | NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY | May 15, 1995 | Substantially Equivalent |
| K932650 | ERYTHROPOIETIN IMMUNOASSAY KIT | Mar 11, 1994 | Substantially Equivalent |
| K931600 | CHEMILUMINESCENCE FREE T3 IMMUNOASSAY | Sep 8, 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 |