FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -
K Number: K834218
·
Decision May 11, 1984
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
8
Review Days
155
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Basic Information
- Device Name
- DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -
- K Number
- K834218
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Tago, Inc.
- Date Received
- December 8, 1983
- Decision Date
- May 11, 1984
- Product Code
- MSJ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| MSJ | Apolipoproteins | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
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Other Clearances by Tago, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841734 | TAGO FIFFU-GEN, OROSOMUCOID | Jun 1, 1984 | Substantially Equivalent |
| K841265 | TAGO DIFFU-GEN C-REACTIVE PROTEIN | May 22, 1984 | Substantially Equivalent |
| K840404 | DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO | Mar 9, 1984 | Substantially Equivalent |
| K833129 | TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 | Nov 21, 1983 | Substantially Equivalent |
| K830611 | RA SCREENING TEST | Mar 24, 1983 | Substantially Equivalent |
| K830531 | MONO SCREENING TEST | Mar 17, 1983 | Substantially Equivalent |
| K830156 | HCG SCREENING TEST | Feb 9, 1983 | Substantially Equivalent |