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510(k) K920974

BACTIDROP ACRIDINE ORANGE by Remel Co. — Product Code JFO

K920974 is an FDA 510(k) premarket notification submitted by Remel Co. for the device "BACTIDROP ACRIDINE ORANGE". The FDA issued a decision of Substantially Equivalent on June 19, 1992. The device falls under product code JFO (Fluorometric, Calcium), a Class II device regulated under 21 CFR 862.1145. Remel Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1992
Date Received
March 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Remel Co.

  • K162620 — Remel Spectra ESBL (May 1, 2017)
  • K131804 — REMEL XPECT FLU A&B (July 12, 2013)
  • K092407 — REMEL SPECTRA MRSA (October 8, 2010)
  • K072827 — RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE (November 26, 2007)
  • K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (November 15, 2004)
  • K033479 — PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY (February 26, 2004)
  • K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (November 18, 2003)
  • K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (November 14, 2003)
  • K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (November 10, 2003)
  • K031565 — XPECT INFLUENZA A/B (July 17, 2003)

FDA data resources