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510(k) K862914

FEKAL CHECK PARASITOLOGY CONTROL SLIDE by Trend Scientific, Inc. — Product Code JTR

K862914 is an FDA 510(k) premarket notification submitted by Trend Scientific, Inc. for the device "FEKAL CHECK PARASITOLOGY CONTROL SLIDE". The FDA issued a decision of Substantially Equivalent on September 16, 1986. The device falls under product code JTR (Kit, Quality Control For Culture Media), a Class I device regulated under 21 CFR 866.2480. Trend Scientific, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1986
Date Received
August 1, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Quality Control For Culture Media
Device Class
Class I
Regulation Number
866.2480
Review Panel
MI
Submission Type

Other clearances by Trend Scientific, Inc.

  • K954996 — TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM (August 8, 1996)
  • K955755 — TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS (July 11, 1996)
  • K952467 — TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) (November 20, 1995)
  • K953284 — TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM (October 6, 1995)
  • K830769 — FEKAL CON-TRATE SYSTEM (April 5, 1983)

Other clearances for product code JTR

  • K871121 — PROTECT T.M. (April 14, 1987)
  • K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (April 4, 1986)
  • K855198 — INDI KWIK (TM) CO/TWO KIT (January 14, 1986)
  • K842579 — B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS (July 27, 1984)
  • K842129 — LYFO-DISK MICROORGANISMS (July 3, 1984)
  • K831653 — LYOPHILIZED MICROORGANISMS (July 28, 1983)
  • K830133 — Q-CHECK CULTI-LOOPS (February 9, 1983)
  • K822954 — MICROTECH BACTERIAL CONTROLS (November 16, 1982)
  • K821660 — BIO-CHECK GRAM STAIN CONTROL (June 25, 1982)
  • K820064 — SUSCEPTROL (January 28, 1982)

FDA data resources