FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIQUI-SERA COMBO LIGAND/TDM CONTROLS
K Number: K863849
·
Decision Nov 24, 1986
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
11
Review Days
55
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
- LIQUI-SERA COMBO LIGAND/TDM CONTROLS
- K Number
- K863849
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biodiagnostic Intl
- Date Received
- September 30, 1986
- Decision Date
- November 24, 1986
- 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 Biodiagnostic Intl
| K Number | Device Name | ||
|---|---|---|---|
| K031296 | LIQUI-HEME GLYCO A1C ASSAY | Oct 15, 2004 | Substantially Equivalent |
| K881430 | LIQUI-SERA SERUM ALCOHOL CONTROLS | Jul 8, 1988 | Substantially Equivalent |
| K874459 | LIQUI-SERA SPINAL FLUID CONTROL | Dec 29, 1987 | Substantially Equivalent |
| K853906 | LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) | Oct 4, 1985 | Substantially Equivalent |
| K853887 | LIQUI-SERA CHEM. MULTIPLE CALIBRATORS | Sep 30, 1985 | Substantially Equivalent |
| K842668 | LIQUI-HEME HEMOGLOBIN CALIBRATORS | Mar 5, 1985 | Substantially Equivalent |
| K840618 | LIQUI-URA CHEMISTRY URINE CONTROLS | Apr 4, 1984 | Substantially Equivalent |
| K834398 | LIQUI-SERA TDM CALIBRATORS | Feb 3, 1984 | Substantially Equivalent |
| K834259 | LIQUI-URA TOXIC URINE CONTROL | Jan 30, 1984 | Substantially Equivalent |
| K831278 | LIQUI-SERA ANTICONVULSANTS CONTROLS | May 27, 1983 | Substantially Equivalent |