FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
K Number: K912725
·
Decision Jul 30, 1991
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
27
Review Days
40
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
- TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
- K Number
- K912725
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Creative Laboratory Products, Inc.
- Date Received
- June 20, 1991
- Decision Date
- July 30, 1991
- Product Code
- JJY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJY), ordered by most recent decision date.
Multichem IA Plus
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Audit MicroControls Linearity FD Tumor Markers II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Liquichek Cardiac Markers Plus Control LT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Creative Laboratory Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950589 | CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL | Mar 20, 1995 | Substantially Equivalent |
| K942284 | CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET | Aug 26, 1994 | Substantially Equivalent |
| K922995 | LIPID CONTROLS | Aug 12, 1992 | Substantially Equivalent |
| K913427 | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET | Nov 19, 1991 | Substantially Equivalent |
| K913371 | TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL | Nov 8, 1991 | Substantially Equivalent |
| K913585 | LIPASE LINEARITY CONTROL | Oct 21, 1991 | Substantially Equivalent |
| K913224 | LIPID LINEARITY CONTROLS | Sep 25, 1991 | Substantially Equivalent |
| K913496 | CHOLINESTERASE LINEARITY CONTROL | Sep 11, 1991 | Substantially Equivalent |
| K912823 | HIGH DENSITY LIPOPROTEIN CHOLESTEROL | Aug 16, 1991 | Substantially Equivalent |
| K904989 | CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II | Jan 23, 1991 | Substantially Equivalent |