FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
K Number: K041619
·
Decision Dec 17, 2004
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
94
Applicant Total
14
Review Days
185
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Basic Information
- Device Name
- BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
- K Number
- K041619
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biocheck, Inc.
- Date Received
- June 15, 2004
- Decision Date
- December 17, 2004
- Product Code
- MMI
- 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 |
|---|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | FDA class 2 | Clinical Chemistry |
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Other Clearances by Biocheck, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |
| 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 |