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510(k) K792699

OUCHTERLONY AGAR PLATES by Meridian Diagnostics, Inc. — Product Code JZQ

K792699 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "OUCHTERLONY AGAR PLATES". The FDA issued a decision of Substantially Equivalent on January 24, 1980. The device falls under product code JZQ (Plates And Equipment, Radial Immunodiffusion), a Class I device regulated under 21 CFR 866.4800. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1980
Date Received
December 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plates And Equipment, Radial Immunodiffusion
Device Class
Class I
Regulation Number
866.4800
Review Panel
IM
Submission Type

Other clearances by Meridian Diagnostics, Inc.

  • K993914 — PREMIER TOXINS A&B, MODEL 616096 (December 10, 1999)
  • K990263 — IMMUNOCARD STAT! E. COLI O157:H7 (August 9, 1999)
  • K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST (June 25, 1999)
  • K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (June 25, 1999)
  • K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA (December 17, 1998)
  • K982764 — PREMIER CRYPTOSPORIDIUM (December 3, 1998)
  • K982711 — PREMIER GIARDIA (November 25, 1998)
  • K980076 — PREMIER PLATINUM HPSA (May 12, 1998)
  • K980077 — PARA-PAK SPINCON (April 2, 1998)
  • K971585 — IMMUNOCARD STAT! ROTAVIRUS (August 20, 1997)

Other clearances for product code JZQ

  • K881174 — RID PLATE READER (June 8, 1988)
  • K881675 — IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS (April 21, 1988)
  • K831811 — REVOLUTION RADIAL IMMUNODIFFUSION PLATE (July 28, 1983)
  • K790646 — HELENA QUIPLATE SYSTEM (May 23, 1979)
  • K770548 — IMMUNOPLATE III RADIO IMMUNODIFFUSION (April 15, 1977)
  • K761311 — ACCRAASSAY RID KITS (December 30, 1976)

FDA data resources