FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DMA ALBUMIN PROCEDURE
K Number: K946355
·
Decision Mar 1, 1995
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
119
Applicant Total
111
Review Days
61
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Basic Information
- Device Name
- DMA ALBUMIN PROCEDURE
- K Number
- K946355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Data Medical Associates, Inc.
- Date Received
- December 30, 1994
- Decision Date
- March 1, 1995
- Product Code
- CIX
- 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 |
|---|---|---|---|
| CIX | Bromcresol Green Dye-Binding, Albumin | FDA class 2 | Clinical Chemistry |
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Other Clearances by Data Medical Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993098 | HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 | Oct 8, 1999 | Substantially Equivalent |
| K971113 | DMA TRIGLYCERIDES PROCEDURES | May 29, 1997 | Substantially Equivalent |
| K961919 | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | Jul 1, 1996 | Substantially Equivalent |
| K955302 | SERUM BICARBONATE/CARBON DIOXIDE | Feb 29, 1996 | Substantially Equivalent |
| K955796 | IRON CALIBRATOR & CALIBRATION VERIFICATION SET | Feb 29, 1996 | Substantially Equivalent |
| K955300 | TOTAL BILIRUBIN PROCEDURE | Dec 20, 1995 | Substantially Equivalent |
| K952437 | DMA GLUCOSE HEXOKINASE U.V. PROCEDURE | Oct 3, 1995 | Substantially Equivalent |
| K946161 | DMA TOTAL CHOLESTEROL PROCEDURE | Aug 23, 1995 | Substantially Equivalent |
| K946354 | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE | May 8, 1995 | Substantially Equivalent |
| K944255 | DMA CALCIUM PLUS PROCEDURE | Dec 6, 1994 | Substantially Equivalent |