FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
N-ASSAY TIA MICROALBUMIN CALIBRATOR SET
K Number: K934143
·
Decision Nov 5, 1993
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
29
Review Days
73
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Basic Information
- Device Name
- N-ASSAY TIA MICROALBUMIN CALIBRATOR SET
- K Number
- K934143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Crestat Diagnostics, Inc.
- Date Received
- August 24, 1993
- Decision Date
- November 5, 1993
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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Other Clearances by Crestat Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980883 | N-ASSAY GLU-UL | Sep 3, 1998 | Substantially Equivalent |
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| 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 |