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510(k) K933997

PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY by Alexon Biomedical, Inc. — Product Code GMD

K933997 is an FDA 510(k) premarket notification submitted by Alexon Biomedical, Inc. for the device "PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY". The FDA issued a decision of Substantially Equivalent on November 22, 1993. The device falls under product code GMD (Antisera, Latex Agglutination, Cryptococcus Neoformans), a Class II device regulated under 21 CFR 866.3165. Alexon Biomedical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1993
Date Received
August 17, 1993
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 Alexon Biomedical, Inc.

  • K964864 — PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY (February 4, 1997)
  • K955157 — PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY (February 9, 1996)
  • K936191 — PROSPECT CRYPTOSPORIDIUM RAPID ASSAY (November 17, 1994)
  • K874849 — PROSPECT/GIARDIA (January 5, 1988)

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)
  • 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)
  • 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