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510(k) K822930

CSM CHROMOGENIC B-LACTAMASE DISC by Carr-Scarborough Microbiologicals, Inc. — Product Code JTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1982
Date Received
October 4, 1982
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)
  • K882630 — PRO DISCS (February 16, 1989)
  • K882636 — ALN DISCS (February 16, 1989)
  • K863216 — NEIS NZY (September 15, 1986)
  • K860301 — RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE (February 6, 1986)
  • K860302 — PYR DISCS (February 5, 1986)

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)