VITROS CHEMISTRY PRODUCTS CRBM SLIDES— 510(k) K980283
Substantially EquivalentJohnson & Johnson Clinical Diagnostics, Inc.
FDA 510(k) clearance K980283 for VITROS CHEMISTRY PRODUCTS CRBM SLIDES, Substantially Equivalent on 1998-02-25. Applicant: Johnson & Johnson Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Product code
- Code KLT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3645
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code KLT
view allMore clearances from Johnson & Johnson Clinical Diagnostics, Inc.
view all- K974644 — VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
- K973517 — VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
- K973030 — VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
- K972133 — VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
- K970894 — VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
Recalls naming K980283
K-number listed on FDA's recall record- Z-1470-2014 — VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
- Z-0307-2014 — VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K980283.
Data sourced from openFDA. This site is unofficial and independent of the FDA.