VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)— 510(k) K964310
Substantially EquivalentJohnson & Johnson Clinical Diagnostics, Inc.
FDA 510(k) clearance K964310 for VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010), Substantially Equivalent on 1996-11-27. Applicant: Johnson & Johnson Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Product code
- Code CDP
- Device class
- Class 2
- Regulation
- 21 CFR 862.1710
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code CDP
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)
Adverse events under product code CDP
product code CDP- Malfunction
- 647
- Total
- 647
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K964310
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964310.
Data sourced from openFDA. This site is unofficial and independent of the FDA.