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510(k) K936191

PROSPECT CRYPTOSPORIDIUM RAPID ASSAY by Alexon Biomedical, Inc. — Product Code MHJ

K936191 is an FDA 510(k) premarket notification submitted by Alexon Biomedical, Inc. for the device "PROSPECT CRYPTOSPORIDIUM RAPID ASSAY". The FDA issued a decision of Substantially Equivalent on November 17, 1994. The device falls under product code MHJ (Cryptosporidium Spp.), a Class II device regulated under 21 CFR 866.3220. Alexon Biomedical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1994
Date Received
December 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cryptosporidium Spp.
Device Class
Class II
Regulation Number
866.3220
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)
  • K933997 — PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY (November 22, 1993)
  • K874849 — PROSPECT/GIARDIA (January 5, 1988)

Other clearances for product code MHJ

  • K171078 — TRI-COMBO PARASITE SCREEN (July 10, 2017)
  • K121565 — UNI-GOLD CRYPTOSPORIDIUM (February 8, 2013)
  • K051929 — GIARDIA/CRYPTOSPORIDIUM CHEK (November 17, 2005)
  • K052932 — CRYPTOSPORIDIUM II (November 4, 2005)
  • K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (November 14, 2003)
  • K031059 — IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 (July 10, 2003)
  • K982764 — PREMIER CRYPTOSPORIDIUM (December 3, 1998)
  • K982709 — MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY (September 3, 1998)
  • K980354 — CRYPTOSPORIDIUM TEST (May 18, 1998)
  • K955852 — CRYPTO-CEL IF TEST (August 5, 1996)

FDA data resources