510(k) K052645
- Device
- VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
- Applicant
- ORTHO-CLINICAL DIAGNOSTICS
- 510(k) number
- K052645
- Product code
- GTQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-12-14
- Date received
- 2005-09-26
- Regulation
- 866.3720
- Classification name
- Antistreptolysin - Titer/streptolysin O Reagent
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL M BYRNE
- Address
- 100 Indigo Creek Dr. Rochester NY US 14626 14626
FDA Registration Numbers#
- 8040374
- 9614373
- 2517506
- 1000403749
- 3003871639
- 3005333358
- 3004493545
- 9680746
- 1319808
- 3000308930
- 2085064
- 1649661
- 1616487
- 1645225
- 3012471076
- 3002642396
- 2029372
- 9610126
- 3003601075
- 9610806
- 2084025
- 3017379203
- 3012963943
- 1832216
- 2250030
- 3021841051
- 1827821
- 2250051
- 2050012
- 3014325803
- 9610746
- 2050010
- 1641328
- 3003741796
- 2432235
- 1319681
Source Documents#
Legacy Summary#
summary
FDA Review#
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