FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
K Number: K052645
·
Decision Dec 14, 2005
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
36
Applicant Total
22
Review Days
79
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
- VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
- K Number
- K052645
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3720
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics
- Date Received
- September 26, 2005
- Decision Date
- December 14, 2005
- 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.
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
BECKMAN ANTISTREPTOLYSIN O, MODIFICATION
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Ortho-Clinical Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K101921 | VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT | Oct 22, 2010 | Substantially Equivalent |
| K083173 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM | Dec 22, 2008 | Substantially Equivalent |
| K063720 | VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS | Apr 9, 2007 | Substantially Equivalent |
| K062165 | VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS | Jan 5, 2007 | Substantially Equivalent |
| K062838 | VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 | Dec 19, 2006 | Substantially Equivalent |
| K060480 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS | Jul 3, 2006 | Substantially Equivalent |
| K042494 | VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III | Oct 19, 2004 | Substantially Equivalent |
| K042303 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS | Sep 27, 2004 | Substantially Equivalent |
| K041764 | THE VITROS 5,1 FS CHEMISTRY SYSTEM | Sep 9, 2004 | Substantially Equivalent |
| K033127 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS | Oct 31, 2003 | Substantially Equivalent |