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510(k) K051929

GIARDIA/CRYPTOSPORIDIUM CHEK by Techlab, Inc. — Product Code MHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2005
Date Received
July 13, 2005
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

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  • K171078 — TRI-COMBO PARASITE SCREEN (July 10, 2017)
  • K170728 — E. HISTOLYTICA QUIK CHEK (June 7, 2017)
  • K082499 — C. DIFF QUIK CHEK COMPLETE (March 26, 2009)
  • K053572 — C. DIFF QUIK CHEK (April 26, 2006)

Other clearances for product code MHJ

  • K171078 — TRI-COMBO PARASITE SCREEN (July 10, 2017)
  • K121565 — UNI-GOLD CRYPTOSPORIDIUM (February 8, 2013)
  • 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)
  • K955755 — TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS (July 11, 1996)