FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD
K Number: K901453
·
Decision Apr 12, 1990
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
32
Applicant Total
44
Review Days
16
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
- QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD
- K Number
- K901453
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Isolab, Inc.
- Date Received
- March 27, 1990
- Decision Date
- April 12, 1990
- Product Code
- DFT
- 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 |
|---|---|---|---|
| DFT | Igm, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DFT), ordered by most recent decision date.
IGM
FDA 510(k)
FDA Class 2
·Immunology
QUANTEX IGM
FDA 510(k)
FDA Class 2
·Immunology
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
RAICHEM(TM) SPIA(TM) IGM REAGENTS
FDA 510(k)
FDA Class 2
·Immunology
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Isolab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951014 | ISOLAB'S T4 TEST KIT | Oct 18, 1996 | Substantially Equivalent |
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | Feb 1, 1996 | Substantially Equivalent |
| K943547 | PHENYLALANINE TEST KIT | Jan 26, 1996 | Substantially Equivalent |
| K950803 | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE | Sep 21, 1995 | Substantially Equivalent |
| K950415 | FLUOROSCAN NEONATAL | Sep 5, 1995 | Substantially Equivalent |
| K942276 | QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY | Jan 20, 1995 | Substantially Equivalent |
| K942222 | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | Jan 20, 1995 | Substantially Equivalent |
| K944185 | ISOSCAN | Nov 17, 1994 | Substantially Equivalent |
| K934013 | RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT | Apr 26, 1994 | Substantially Equivalent |
| K923153 | HEMOCARD, HEMOGLOBIN C ASSAY | Jan 27, 1994 | Substantially Equivalent |