FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNCHRON C-REACTIVE PROTEIN REAGENT
K Number: K910535
·
Decision Apr 12, 1991
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
281
Review Days
63
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Basic Information
- Device Name
- SYNCHRON C-REACTIVE PROTEIN REAGENT
- K Number
- K910535
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Beckman Instruments, Inc.
- Date Received
- February 8, 1991
- Decision Date
- April 12, 1991
- Product Code
- DCN
- 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 |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | FDA class 2 | Immunology |
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Other Clearances by Beckman Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K981403 | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT | May 8, 1998 | Substantially Equivalent |
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| K980173 | ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 | Mar 18, 1998 | Substantially Equivalent |
| K974816 | ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 | Feb 20, 1998 | Substantially Equivalent |
| K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | Feb 17, 1998 | Substantially Equivalent |
| K974110 | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | Dec 24, 1997 | Substantially Equivalent |
| K974452 | VIGIL LIPID CONTROL | Dec 17, 1997 | Substantially Equivalent |
| K973932 | BECKMAN CALIBRATOR 2 (CAL2) | Dec 15, 1997 | Substantially Equivalent |