FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
K Number: K001022
·
Decision Sep 26, 2000
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
52
Applicant Total
14
Review Days
180
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Basic Information
- Device Name
- BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
- K Number
- K001022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5630
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biocheck, Inc.
- Date Received
- March 30, 2000
- Decision Date
- September 26, 2000
- Product Code
- JZG
- 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 |
|---|---|---|---|
| JZG | System, Test, Beta-2-Microglobulin Immunological | FDA class 2 | Immunology |
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Other Clearances by Biocheck, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041619 | BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 | Dec 17, 2004 | Substantially Equivalent |
| K040030 | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 | Jun 16, 2004 | Substantially Equivalent |
| K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | Dec 19, 2002 | Substantially Equivalent |
| K013062 | BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT | Jan 8, 2002 | Substantially Equivalent |
| 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 |
| K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | Sep 24, 1999 | Substantially Equivalent |
| K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | Sep 21, 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 |