FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
K Number: K981354
·
Decision May 1, 1998
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
281
Review Days
17
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Basic Information
- Device Name
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
- K Number
- K981354
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Instruments, Inc.
- Date Received
- April 14, 1998
- Decision Date
- May 1, 1998
- Product Code
- LOJ
- 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 |
|---|---|---|---|
| LOJ | Kit, Test,Alpha-Fetoprotein For Testicular Cancer | FDA class 2 | Immunology |
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FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Beckman Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973448 | ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 | Sep 17, 1998 | Substantially Equivalent |
| K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Jul 14, 1998 | Substantially Equivalent |
| K981403 | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT | May 8, 1998 | Substantially Equivalent |
| 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 |
| K973928 | BECKMAN URINE PROTEIN CALIBRATOR (UCAL) | Dec 1, 1997 | Substantially Equivalent |