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510(k) K860301

RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE by Carr-Scarborough Microbiologicals, Inc. — Product Code JTO

K860301 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE". The FDA issued a decision of Substantially Equivalent on February 6, 1986. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Carr-Scarborough Microbiologicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1986
Date Received
January 28, 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 Carr-Scarborough Microbiologicals, Inc.

  • K944554 — BRAIN HEART INFUSION AGAR (October 4, 1994)
  • K941985 — MUELLER HINTON AGAR W/OXACILLIN (August 24, 1994)
  • K905472 — LAP DISCS (February 27, 1991)
  • K905666 — M. CAT. BUTYRATE DISC (February 26, 1991)
  • K891476 — C. ALBICANS SCREEN (April 12, 1989)
  • K882636 — ALN DISCS (February 16, 1989)
  • K882630 — PRO DISCS (February 16, 1989)
  • K863216 — NEIS NZY (September 15, 1986)
  • K860302 — PYR DISCS (February 5, 1986)
  • K822930 — CSM CHROMOGENIC B-LACTAMASE DISC (November 1, 1982)

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