EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)— 510(k) K953197
Substantially EquivalentJohnson & Johnson Clinical Diagnostics, Inc.
FDA 510(k) clearance K953197 for EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP), Substantially Equivalent on 1995-07-31. Applicant: Johnson & Johnson Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code DCK
view allMore clearances from Johnson & Johnson Clinical Diagnostics, Inc.
view all- K980283 — VITROS CHEMISTRY PRODUCTS CRBM SLIDES
- 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)
Recalls naming K953197
K-number listed on FDA's recall record- Z-1876-2025 — VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
- Z-0535-2025 — VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
- Z-0864-2017 — VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K953197.
Data sourced from openFDA. This site is unofficial and independent of the FDA.