FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)
K Number: K852247
·
Decision Jul 10, 1985
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
18
Applicant Total
145
Review Days
48
Basic Information
- Device Name
- LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)
- K Number
- K852247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5210
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- BEHRING DIAGNOSTICS, INC.
- Date Received
- May 23, 1985
- Decision Date
- July 10, 1985
- Product Code
- DDB
- 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 |
|---|---|---|---|
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K972840 | N ANTISERUM TO HUMAN TRANSFERRIN | Oct 17, 1997 | Substantially Equivalent |
| K973202 | MODIFICATION OF OPUS FERRITIN TEST SYSTEM | Sep 12, 1997 | Substantially Equivalent |
| K972316 | OPUS D-DIMER | Sep 9, 1997 | Substantially Equivalent |
| K972116 | VON WILLEBRAND REAGENT | Jul 25, 1997 | Substantially Equivalent |
| K972011 | OPUS ETHANOL | Jul 22, 1997 | Substantially Equivalent |
| K971600 | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) | Jun 25, 1997 | Substantially Equivalent |
| K971596 | EMIT II OPIATES 300/2000 ASSAY | Jun 25, 1997 | Substantially Equivalent |
| K964595 | OPUS PSA TEST SYSTEM | Jun 24, 1997 | Substantially Equivalent |