FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
N-ASSAY TIA MULTI V-NL
K Number: K964299
·
Decision Jul 14, 1997
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
10
Applicant Total
29
Review Days
258
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Basic Information
- Device Name
- N-ASSAY TIA MULTI V-NL
- K Number
- K964299
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5420
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Crestat Diagnostics, Inc.
- Date Received
- October 29, 1996
- Decision Date
- July 14, 1997
- Product Code
- LKL
- 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 |
|---|---|---|---|
| LKL | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | FDA class 1 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKL), ordered by most recent decision date.
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IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
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AL-ACID GLYCOPROTEIN RID KIT
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RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
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TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
FDA 510(k)
FDA Class 1
·Immunology
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
FDA 510(k)
FDA Class 1
·Immunology
Other Clearances by Crestat Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980883 | N-ASSAY GLU-UL | Sep 3, 1998 | Substantially Equivalent |
| K981276 | N-ASSAY L D-BIL | May 1, 1998 | Substantially Equivalent |
| K981289 | N-ASSAY L T-BIL | Apr 27, 1998 | Substantially Equivalent |
| K980902 | N-ASSAY L AST/GOT | Mar 26, 1998 | Substantially Equivalent |
| K980900 | N-ASSAY CPK-L | Mar 26, 1998 | Substantially Equivalent |
| K971985 | N-ASSAY TIA PLASMINOGEN TEST KIT | Oct 20, 1997 | Substantially Equivalent |
| K972257 | N-ASSAY TIA ANTITHROMBIN III TEST KIT | Oct 20, 1997 | Substantially Equivalent |
| K964296 | N-ASSAY TIA APO B TEST KIT | Aug 1, 1997 | Substantially Equivalent |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | Aug 1, 1997 | Substantially Equivalent |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | Aug 1, 1997 | Substantially Equivalent |