FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)
K Number: K890530
·
Decision Mar 27, 1989
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
145
Review Days
53
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
- N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)
- K Number
- K890530
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Behring Diagnostics, Inc.
- Date Received
- February 2, 1989
- Decision Date
- March 27, 1989
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DGC), ordered by most recent decision date.
Kenota 1 Total IgE; Kenota 1 (instrument)
FDA 510(k)
FDA Class 2
·Immunology
Quantia IgE
FDA 510(k)
FDA Class 2
·Immunology
Total Immunoglobulin E (IgE)
FDA 510(k)
FDA Class 2
·Immunology
ADVIA Centaur Total IgE (tIgE)
FDA 510(k)
FDA Class 2
·Immunology
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
FDA 510(k)
FDA Class 2
·Immunology
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Behring Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973832 | OPUS HLH CONTROLS | Oct 27, 1997 | Substantially Equivalent |
| K972929 | N ANTISERUM TO HUMAN ALBUMIN | Oct 20, 1997 | Substantially Equivalent |
| 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 |