BACTIDROP ACRIDINE ORANGE— 510(k) K920974

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K920974 for BACTIDROP ACRIDINE ORANGE, Substantially Equivalent on 1992-06-19. Applicant: Remel Co.. Device class: 2.

Clearance details

Applicant
Remel Co.
Product code
Code JFO
Device class
Class 2
Regulation
21 CFR 862.1145
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lenexa, KS, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K920974

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K920974.

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