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510(k) K834067

LEGIONELLA DIFFERENTIATION DISK by Remel Co. — Product Code GRO

K834067 is an FDA 510(k) premarket notification submitted by Remel Co. for the device "LEGIONELLA DIFFERENTIATION DISK". The FDA issued a decision of Substantially Equivalent on January 3, 1984. The device falls under product code GRO (Antisera, Fluorescent, All Types, Hemophilus Spp.), a Class II device regulated under 21 CFR 866.3300. Remel Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
November 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Types, Hemophilus Spp.
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
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 GRO

  • K851271 — LEGIONELLA CULTURE CONFIRMATIN KIT (July 8, 1985)
  • K802423 — PHADEBACT HAEMOPHILUS TEST (November 12, 1980)
  • K800493 — BACTOGEN-H. INFLUENZAE TYPE B (April 4, 1980)

FDA data resources