FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAT-A-COUNT GENTAMICIN RIA KIT
K Number: K811844
·
Decision Jul 10, 1981
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
18
Applicant Total
321
Review Days
9
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
- COAT-A-COUNT GENTAMICIN RIA KIT
- K Number
- K811844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3450
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Products Corp.
- Date Received
- July 1, 1981
- Decision Date
- July 10, 1981
- Product Code
- DJB
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DJB), ordered by most recent decision date.
AMES TDA SISOMICIN TEST-CONTROL SERUM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GENTAMICIN TEST PACK-ACA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AMES TDA GENTAMICIN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MRI GENTAMICIN RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GAMMA STICK GENTAMICIN RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
QUANTIMUNE GENTAMICIN RIA GENTAMICIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Diagnostic Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | Dec 5, 2006 | Substantially Equivalent |
| K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | Jan 21, 2004 | Substantially Equivalent |
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | Dec 12, 2003 | Substantially Equivalent |
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE | Oct 10, 2003 | Substantially Equivalent |
| K023152 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE | Dec 17, 2002 | Substantially Equivalent |
| K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL | Dec 9, 2002 | Substantially Equivalent |
| K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | Aug 21, 2002 | Substantially Equivalent |
| K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Jul 22, 2002 | Substantially Equivalent |
| K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | Jun 3, 2002 | Substantially Equivalent |
| K021208 | IMMULITE 2000 MIXED ALLERGEN PANELS | May 30, 2002 | Substantially Equivalent |