VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)— 510(k) K970643
Substantially EquivalentJohnson & Johnson Clinical Diagnostics, Inc.
FDA 510(k) clearance K970643 for VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050), Substantially Equivalent on 1997-03-18. Applicant: Johnson & Johnson Clinical Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Product code
- Code CHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1260
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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More clearances from Johnson & Johnson Clinical Diagnostics, Inc.
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- K973517 — VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
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Recalls naming K970643
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 K970643.
Data sourced from openFDA. This site is unofficial and independent of the FDA.