STREP SELECTIVE II— 510(k) K843193

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K843193 for STREP SELECTIVE II, Substantially Equivalent on 1984-09-14. Applicant: Remel Co.. Device class: 1.

Clearance details

Applicant: Remel Co.
Product code: Code JSI
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1984-08-14
Decision date: 1984-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Remel Co.

Recalls naming K843193

K-number listed on FDA's recall record

Z-2224-2025 — Strep Selective II Agar, Product Number R01859Class II·Ongoing·Remel, Inc·20250711

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K843193.

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