TODD HEWITT W/CNA (LIM BROTH)— 510(k) K871447

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K871447 for TODD HEWITT W/CNA (LIM BROTH), Substantially Equivalent on 1987-05-13. Applicant: Remel Co.. Device class: 1.

Clearance details

Applicant: Remel Co.
Product code: Code JSD
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1987-04-13
Decision date: 1987-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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More clearances from Remel Co.

Recalls naming K871447

K-number listed on FDA's recall record

Z-2531-2023 — remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial floraClass II·Ongoing·Remel, Inc·20230814

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K871447.

Data sourced from openFDA. This site is unofficial and independent of the FDA.