FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPQ(TM) ANTIBODY REAGENT SET II FOR C4
K Number: K890564
·
Decision Feb 17, 1989
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
33
Applicant Total
18
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SPQ(TM) ANTIBODY REAGENT SET II FOR C4
- K Number
- K890564
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Atlantic Antibodies
- Date Received
- January 24, 1989
- Decision Date
- February 17, 1989
- Product Code
- DBI
- 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 |
|---|---|---|---|
| DBI | Complement C4, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DBI), ordered by most recent decision date.
SPAPLUS ANALYZER
FDA 510(k)
FDA Class 2
·Immunology
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
WAKO AUTOKIT C4
FDA 510(k)
FDA Class 2
·Immunology
RANDOX COMPLEMENT C4
FDA 510(k)
FDA Class 2
·Immunology
DIMENSION C4 FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Immunology
C4 MININEPH ANTISERUM
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Atlantic Antibodies
| K Number | Device Name | ||
|---|---|---|---|
| K892526 | SPQ TM TEST SYSTEM II FOR CRP | May 9, 1989 | Substantially Equivalent |
| K891154 | SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B | Mar 16, 1989 | Substantially Equivalent |
| K890563 | SPQ(TM) ANTIBODY REAGENT SET II FOR TRF | Mar 3, 1989 | Substantially Equivalent |
| K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | Feb 23, 1989 | Substantially Equivalent |
| K890562 | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT | Feb 22, 1989 | Substantially Equivalent |
| K890416 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGG | Feb 22, 1989 | Substantially Equivalent |
| K890417 | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 | Feb 17, 1989 | Substantially Equivalent |
| K890415 | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT | Feb 17, 1989 | Substantially Equivalent |
| K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | Feb 15, 1989 | Substantially Equivalent |
| K884297 | SPQ(TM) TEST SYSTEM FOR PREALBUMIN | Nov 2, 1988 | Substantially Equivalent |