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510(k) K891476

C. ALBICANS SCREEN by Carr-Scarborough Microbiologicals, Inc. — Product Code JXC

K891476 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "C. ALBICANS SCREEN". The FDA issued a decision of Substantially Equivalent on April 12, 1989. The device falls under product code JXC (Kit, Screening, Yeast), 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
April 12, 1989
Date Received
March 16, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Yeast
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)
  • K882636 — ALN DISCS (February 16, 1989)
  • K882630 — PRO 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)
  • K822930 — CSM CHROMOGENIC B-LACTAMASE DISC (November 1, 1982)

Other clearances for product code JXC

  • K960075 — CHROMAGAR CANDIDA (August 2, 1996)
  • K913426 — ALBICANS SURE (April 22, 1992)
  • K884720 — GERM TUBE SOLUTION (June 2, 1989)
  • K882371 — SOC SLIDE CULTURE SYSTEM (July 18, 1988)
  • K832406 — QUANTUM II YEAST IDENT. SYSTEM (September 26, 1983)

FDA data resources