VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)— 510(k) K964720
Substantially EquivalentJohnson & Johnson Clinical Diagnostics, Inc.
FDA 510(k) clearance K964720 for VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005), Substantially Equivalent on 1997-02-04. Applicant: Johnson & Johnson Clinical Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Product code
- Code CGJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1300
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code CGJ
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 K964720
K-number listed on FDA's recall record- Z-1112-2022 — VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
- Z-0059-2019 — VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964720.
Data sourced from openFDA. This site is unofficial and independent of the FDA.