FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIA-PACK B12 ASSAY
K Number: K964348
·
Decision Jan 13, 1997
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
77
Applicant Total
41
Review Days
74
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Basic Information
- Device Name
- AIA-PACK B12 ASSAY
- K Number
- K964348
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tosoh Medics, Inc.
- Date Received
- October 31, 1996
- Decision Date
- January 13, 1997
- Product Code
- CDD
- 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 |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | Aug 16, 2001 | Substantially Equivalent |
| K992365 | AIA-PACK FOLATE ASSAY | Aug 10, 1999 | Substantially Equivalent |
| K990431 | AIA-PACK CA 125 | Jun 3, 1999 | Substantially Equivalent |