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510(k) K792693

CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX by Meridian Diagnostics, Inc. — Product Code GMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1980
Date Received
December 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Latex Agglutination, Cryptococcus Neoformans
Device Class
Class II
Regulation Number
866.3165
Review Panel
MI
Submission Type

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  • 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 GMD

  • K112422 — CRAG LATERAL FLOW ASSAY (LFA) (March 28, 2012)
  • K102286 — CRAG LATERAL FLOW ASSAY (CRAG LFA) (July 20, 2011)
  • K930418 — CRYPTO-LEX SYSTEM (February 17, 1994)
  • K933997 — PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY (November 22, 1993)
  • K894845 — (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE (September 8, 1989)
  • K812188 — CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI (August 31, 1981)
  • K810510 — YA-CRYPTO ANTIBODY TUBE AGGLUTINATION (March 20, 1981)
  • K791382 — CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION (August 16, 1979)
  • K780526 — CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM (April 28, 1978)