FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN
K Number: K853174
·
Decision Aug 22, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
12
Review Days
23
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Basic Information
- Device Name
- APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN
- K Number
- K853174
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Photec Diagnostics, Inc.
- Date Received
- July 30, 1985
- Decision Date
- August 22, 1985
- 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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APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
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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 Photec Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K897169 | QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT | Feb 23, 1990 | Substantially Equivalent |
| K896329 | D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. | Dec 12, 1989 | Substantially Equivalent |
| K894057 | QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT | Aug 31, 1989 | Substantially Equivalent |
| K892224 | D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN | Jun 16, 1989 | Substantially Equivalent |
| K890267 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA | Apr 26, 1989 | Substantially Equivalent |
| K890027 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD | Apr 26, 1989 | Substantially Equivalent |
| K882307 | D-CHEM | Aug 2, 1988 | Substantially Equivalent |
| K880291 | THEOPHYLLINE TEST KIT REF. #A874799 | Mar 24, 1988 | Substantially Equivalent |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | Jan 24, 1986 | Substantially Equivalent |
| K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | Aug 28, 1985 | Substantially Equivalent |