FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK
K Number: K933648
·
Decision Sep 24, 1993
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
52
Applicant Total
28
Review Days
59
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Basic Information
- Device Name
- ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK
- K Number
- K933648
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5630
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dupont Medical Products
- Date Received
- July 27, 1993
- Decision Date
- September 24, 1993
- Product Code
- JZG
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| JZG | System, Test, Beta-2-Microglobulin Immunological | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZG), ordered by most recent decision date.
Beta-2-Microglobulin
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ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
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HUMAN BETA-2 MICROGLOBULIN KIT
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DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
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QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Dupont Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K952815 | DUPONT LIPASE CALIBRATOR | Aug 31, 1995 | Substantially Equivalent |
| K950920 | DUPONT DIMENSION TOTAL PROTEIN METHOD | Aug 11, 1995 | Substantially Equivalent |
| K952816 | LIPASE FLEX REAGENT CARTRIDGE | Jul 20, 1995 | Substantially Equivalent |
| K952412 | DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL | Jun 23, 1995 | Substantially Equivalent |
| K945280 | DUPONT DIMENSION C-REACTIVE PROTEIN METHOD | Mar 9, 1995 | Substantially Equivalent |
| K944932 | PHENOBARBITAL FLEX REAGENT CARTRIDGE | Dec 28, 1994 | Substantially Equivalent |
| K941050 | DUPONT ACA STAR | Nov 10, 1994 | Substantially Equivalent |
| K943996 | DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD | Oct 20, 1994 | Substantially Equivalent |
| K941146 | DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM | Oct 3, 1994 | Substantially Equivalent |
| K942640 | DUPONT DIMENSION AMYLASE METHOD | Sep 9, 1994 | Substantially Equivalent |