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510(k) K031965

XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 by Remel, Inc. — Product Code MHJ

K031965 is an FDA 510(k) premarket notification submitted by Remel, Inc. for the device "XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020". The FDA issued a decision of Substantially Equivalent on November 14, 2003. The device falls under product code MHJ (Cryptosporidium Spp.), a Class II device regulated under 21 CFR 866.3220. Remel, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2003
Date Received
June 26, 2003
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 Remel, Inc.

  • K162620 — Remel Spectra ESBL (May 1, 2017)
  • K131804 — REMEL XPECT FLU A&B (July 12, 2013)
  • K092407 — REMEL SPECTRA MRSA (October 8, 2010)
  • K072827 — RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE (November 26, 2007)
  • K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (November 15, 2004)
  • K033479 — PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY (February 26, 2004)
  • K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (November 18, 2003)
  • K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (November 10, 2003)
  • K031565 — XPECT INFLUENZA A/B (July 17, 2003)
  • K013711 — BACTI-SWAB DRY (November 26, 2001)

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)
  • 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)
  • K955755 — TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS (July 11, 1996)

FDA data resources