VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
FDA 510(k) clearance K052645 · decided 2005-12-14
Clearance details
- K-number
- K052645
- Device name
- VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
- Applicant
- Ortho-Clinical Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2005-09-26
- Decision date
- 2005-12-14
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- GTQ
- Device class
- 1
- Regulation number
- 866.3720
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT (K953437) | Olympus America, Inc. | 1995-10-20 |
| TURBIQUANT ASL (K915742) | Behring Diagnostics, Inc. | 1993-06-28 |
| BECKMAN ANTI-STREPTOLYSIN O KIT (K926236) | Beckman Instruments, Inc. | 1993-06-15 |
| ACCUTEX ASO LATEX TEST (K924247) | J.S. Medical Assoc. | 1992-12-07 |
| TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (K922723) | Simplicity Diagnostics, Inc. | 1992-09-18 |
| BECKMAN ANTISTREPTOLYSIN O, MODIFICATION (K915053) | Beckman Instruments, Inc. | 1992-03-19 |
| BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT (K912150) | Beckman Instruments, Inc. | 1991-07-17 |
| CROATEST (R) RHEUMATOID DIAGNOSTIC (K904416) | Biotrax, Inc. | 1991-06-24 |
| QM300 CALIBRATOR G PACK (K910885) | Kallestad Diag, A Div. of Erbamont, Inc. | 1991-06-17 |
| QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK (K910886) | Kallestad Diag, A Div. of Erbamont, Inc. | 1991-06-17 |
| QM300 CONTROL G PACK (K910887) | Kallestad Diag, A Div. of Erbamont, Inc. | 1991-06-17 |
| TARGET ASO TEST (K910073) | Texas Immunology, Inc. | 1991-05-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017) | Ortho-Clinical Diagnostics | 2023-01-24 |
| VITROS Anti-HBe (P100001/S016) | Ortho-Clinical Diagnostics | 2019-06-19 |
| VITROS Anti-HBc (P030024/S029) | Ortho-Clinical Diagnostics | 2019-06-19 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028) | Ortho-Clinical Diagnostics | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015) | Ortho-Clinical Diagnostics | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027) | Ortho-Clinical Diagnostics | 2018-10-16 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025) | Ortho-Clinical Diagnostics | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026) | Ortho-Clinical Diagnostics | 2018-07-02 |