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510(k) K860091

BIO SPEC GRAMAFLUOR TEST KIT by Bio Spec, Inc. — Product Code JTO

K860091 is an FDA 510(k) premarket notification submitted by Bio Spec, Inc. for the device "BIO SPEC GRAMAFLUOR TEST KIT". The FDA issued a decision of Substantially Equivalent on January 21, 1986. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Bio Spec, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1986
Date Received
January 10, 1986
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 Bio Spec, Inc.

  • K860041 — STREP D FLUOR (January 24, 1986)
  • K841479 — BIO SPEC STREP-A-FLUOR TEST KIT (April 25, 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