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510(k) K894845

(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE by Meridian Diagnostics, Inc. — Product Code GMD

K894845 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE". The FDA issued a decision of Substantially Equivalent on September 8, 1989. The device falls under product code GMD (Antisera, Latex Agglutination, Cryptococcus Neoformans), a Class II device regulated under 21 CFR 866.3165. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1989
Date Received
August 11, 1989
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

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 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)
  • K812188 — CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI (August 31, 1981)
  • K810510 — YA-CRYPTO ANTIBODY TUBE AGGLUTINATION (March 20, 1981)
  • K792693 — CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX (January 21, 1980)
  • K791382 — CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION (August 16, 1979)
  • K780526 — CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM (April 28, 1978)

FDA data resources