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510(k) K955755

TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS by Trend Scientific, Inc. — Product Code MHJ

K955755 is an FDA 510(k) premarket notification submitted by Trend Scientific, Inc. for the device "TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS". The FDA issued a decision of Substantially Equivalent on July 11, 1996. The device falls under product code MHJ (Cryptosporidium Spp.), a Class II device regulated under 21 CFR 866.3220. Trend Scientific, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1996
Date Received
December 20, 1995
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 Trend Scientific, Inc.

  • K954996 — TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM (August 8, 1996)
  • K952467 — TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) (November 20, 1995)
  • K953284 — TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM (October 6, 1995)
  • K862914 — FEKAL CHECK PARASITOLOGY CONTROL SLIDE (September 16, 1986)
  • K830769 — FEKAL CON-TRATE SYSTEM (April 5, 1983)

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