FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAPID AS LATEX
K Number: K862530
·
Decision Apr 21, 1987
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
36
Applicant Total
11
Review Days
293
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
- RAPID AS LATEX
- K Number
- K862530
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3720
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Dilab, Inc.
- Date Received
- July 2, 1986
- Decision Date
- April 21, 1987
- Product Code
- GTQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GTQ), ordered by most recent decision date.
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
FDA 510(k)
FDA Class 1
·Microbiology
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
FDA 510(k)
FDA Class 1
·Microbiology
TURBIQUANT ASL
FDA 510(k)
FDA Class 1
·Microbiology
BECKMAN ANTI-STREPTOLYSIN O KIT
FDA 510(k)
FDA Class 1
·Microbiology
ACCUTEX ASO LATEX TEST
FDA 510(k)
FDA Class 1
·Microbiology
TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Dilab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850931 | ALBUMIN | Jun 26, 1985 | Substantially Equivalent |
| K850938 | CHOLESTEROL | Jun 25, 1985 | Substantially Equivalent |
| K850936 | TOTAL PROTEINS | Jun 25, 1985 | Substantially Equivalent |
| K850932 | CREATININE | Jun 25, 1985 | Substantially Equivalent |
| K850933 | URIC ACID | Jun 25, 1985 | Substantially Equivalent |
| K850934 | PHOSPHORUS | Jun 25, 1985 | Substantially Equivalent |
| K850935 | CHLORIDE | Jun 10, 1985 | Substantially Equivalent |
| K850937 | UREA | Jun 10, 1985 | Substantially Equivalent |
| K850930 | GLUCOSE | Jun 10, 1985 | Substantially Equivalent |
| K850929 | CALCIUM | Jun 10, 1985 | Substantially Equivalent |