FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
K Number: K942222
·
Decision Jan 20, 1995
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
11
Applicant Total
44
Review Days
259
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 QUANTITIVE HEMOGLOBIN S CONTROLS
- K Number
- K942222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7415
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isolab, Inc.
- Date Received
- May 6, 1994
- Decision Date
- January 20, 1995
- Product Code
- JCM
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JCM | Control, Hemoglobin, Abnormal | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JCM), ordered by most recent decision date.
EXTENDSURE HBFASC CONTROL
FDA 510(k)
FDA Class 2
·Hematology
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
FDA 510(k)
FDA Class 2
·Hematology
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
FDA 510(k)
FDA Class 2
·Hematology
HEMOCARD CONTROL HB-AA, AE, FAA, FAE
FDA 510(k)
FDA Class 2
·Hematology
HEMOCARD(TM) CONTROL
FDA 510(k)
FDA Class 2
·Hematology
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 |
| 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 |
| K931234 | HEMOCARD CONTROL HB-AA, AE, FAA, FAE | May 11, 1993 | Substantially Equivalent |