FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOCHECK IGE ELISA, MODEL BC-1035
K Number: K992528
·
Decision Sep 21, 1999
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
14
Review Days
55
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Basic Information
- Device Name
- BIOCHECK IGE ELISA, MODEL BC-1035
- K Number
- K992528
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biocheck, Inc.
- Date Received
- July 28, 1999
- Decision Date
- September 21, 1999
- 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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|---|---|---|---|
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| K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | Dec 19, 2002 | Substantially Equivalent |
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| K003851 | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 | Jul 20, 2001 | Substantially Equivalent |
| K002294 | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 | Oct 2, 2000 | Substantially Equivalent |
| K001022 | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | Sep 26, 2000 | Substantially Equivalent |
| K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | Sep 24, 1999 | Substantially Equivalent |
| K991741 | BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 | Jul 22, 1999 | Substantially Equivalent |
| K991146 | TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 | Jun 22, 1999 | Substantially Equivalent |