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510(k) K843316

INDOLE SPOT TEST KIT 270-25 by Applied Polytechnology, Inc. — Product Code JTO

K843316 is an FDA 510(k) premarket notification submitted by Applied Polytechnology, Inc. for the device "INDOLE SPOT TEST KIT 270-25". The FDA issued a decision of Substantially Equivalent on September 11, 1984. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Applied Polytechnology, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1984
Date Received
August 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Applied Polytechnology, Inc.

  • K860483 — FILTRA-CHECK-UTI (April 4, 1986)
  • K843834 — BACTERIURIA DETECT. DEVICE APTEK II (November 29, 1984)
  • K843833 — BACTERIURIA DETECT DEVICE, MULTI SAMPLER (November 29, 1984)
  • K843359 — URINE TRANSPORT KIT (September 27, 1984)
  • K840257 — RAPID IMMUNO-ASSAY SYS (April 19, 1984)
  • K834264 — REVERSE-FLOW SYSTEM (January 13, 1984)

Other clearances for product code JTO

  • K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (September 1, 2005)
  • K970832 — PYR SWAB (April 24, 1997)
  • K970834 — GRAM SWAB (April 17, 1997)
  • K970833 — INDOLE SWAB (April 2, 1997)
  • K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (February 6, 1997)
  • K962966 — IDS RAPID CB PLUS SYSTEM (October 8, 1996)
  • K961191 — COLISCREEN (June 17, 1996)
  • K960996 — M. CAT BUTYRATE DISK (April 18, 1996)
  • K955826 — GIBSON ID-M. CAT. (February 29, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)

FDA data resources