FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
K Number: K940183
·
Decision May 17, 1994
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
51
Review Days
125
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Basic Information
- Device Name
- HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
- K Number
- K940183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hycor Biomedical, Inc.
- Date Received
- January 12, 1994
- Decision Date
- May 17, 1994
- Product Code
- DGC
- 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 |
|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Hycor Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081217 | HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM | May 22, 2008 | Substantially Equivalent |
| K080322 | HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 | Mar 5, 2008 | Substantially Equivalent |
| K022944 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA | Dec 18, 2002 | Substantially Equivalent |
| K022945 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA | Dec 18, 2002 | Substantially Equivalent |
| K965094 | HYCOR ALLERGEN DISC | May 21, 1997 | Substantially Equivalent |
| K962730 | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY | Mar 7, 1997 | Substantially Equivalent |
| K962720 | HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY | Mar 7, 1997 | Substantially Equivalent |
| K962729 | HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY | Mar 7, 1997 | Substantially Equivalent |
| K962578 | HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY | Mar 7, 1997 | Substantially Equivalent |
| K962722 | HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY | Mar 7, 1997 | Substantially Equivalent |