VITROS CHEMISTRY PRODUCTS PHBR SLIDES— 510(k) K984288
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K984288 for VITROS CHEMISTRY PRODUCTS PHBR SLIDES, Substantially Equivalent on 1999-01-26. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code DLZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3660
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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Recalls naming K984288
K-number listed on FDA's recall record- Z-0319-2014 — VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
- Z-1152-2013 — VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K984288.
Data sourced from openFDA. This site is unofficial and independent of the FDA.