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510(k) K803304

ACRIDINE ORANGE STAIN by Remel Co. — Product Code IDC

K803304 is an FDA 510(k) premarket notification submitted by Remel Co. for the device "ACRIDINE ORANGE STAIN". The FDA issued a decision of Substantially Equivalent on February 12, 1981. The device falls under product code IDC (Acridine Orange), a Class I device regulated under 21 CFR 864.1850. Remel Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1981
Date Received
December 30, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acridine Orange
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
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)

Other clearances for product code IDC

  • K853187 — ACRIDINE ORANGE FLUORESCENT STAIN (August 13, 1985)
  • K812212 — ACRIDINE ORANGE STAIN (September 1, 1981)
  • K810040 — ACRIDINE ORANGE STAIN (February 12, 1981)

FDA data resources